Surgical Instrumentation And Methods Of Use For Implanting A Prosthesis

ABSTRACT

A tissue resection guide for use with a datum includes a base releasably engagable with the datum. The tissue resection guide has a first frame fixed relative to the base and the first frame has at least one integral first guide path that is sized and configured to at least partially capture and guide a first tissue resection tool relative to the first frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/637,746 filed Jun. 29, 2017, which is a continuation of U.S.application Ser. No. 15/294,307 filed Oct. 14, 2016, which is acontinuation of U.S. application Ser. No. 13/001,080, filed Feb. 10,2012, which is a national phase entry under 35 U.S.C § 371 ofInternational Application No. PCT/US2009/48699 filed Jun. 25, 2009,published in English, which claims the benefit of U.S. ProvisionalPatent Application No. 61/133,186 filed Jun. 25, 2008 and entitled“Instrumentation for Prosthesis” and U.S. Provisional Patent ApplicationNo. 61/178,343 filed May 14, 2009, and entitled “SurgicalInstrumentation and Methods of Use for Implanting an Endoprothesis,” thedisclosures of which are hereby incorporated by reference herein intheir entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to surgical instrumentation andmethods for such procedures such as, for example, a total jointreplacement within a patient.

Various endoprosthetic devices are known for repairing or replacingjoints in a patient. Specifically, it is known to use an endoprosthesisto replace a damaged ankle joint. The ankle joint is a comparativelysmall joint relative to the weight bearing and torque the joint mustwithstand. These factors have made the design of total ankle jointreplacements technically challenging. Total ankle replacement has beeninvestigated since the 1970's with initially promising results, but theprocedure was essentially abandoned in the 1980's due to a highlong-term failure rate, both in terms of pain control and improvedfunction. However, researchers have continued to investigate newdesigns, which can be broadly subdivided into constrained andunconstrained designs. Constrained designs offer the advantage ofgreater stability, but with decreased mobility and increased stress atthe bone implant interface, potentially leading to a greater risk ofearly loosening and failure. Unconstrained designs provide improvedrange of motion in multiple planes, but at the expense of stability.Early devices investigated were implanted with cement fixation, which inrecent years has given way to cementless designs. One such cementless,non-constrained mobile bearing device that has proven to be successfulis a total ankle replacement. An example of the total ankle replacement,shown in FIGS. 1 and 2, is further described in U.S. Pat. No. 6,852,130and is commercially known as the S.T.A.R.® or the Scandinavian TotalAnkle Replacement System.

Total joint replacements, such as the S.T.A.R.®, have been implanted torepair damaged joints using a combination of cut guides and free handcutting and shaping to sufficiently prepare the bone contacting thetotal joint replacement.

It would be desirable to reduce the amount of measuring, free handcutting and/or re-mounting of cut guides to the remaining healthy bonestructure to efficiently and accurately prepare the resected tissuesurface receiving the total joint replacement with repeatable resultsand minimum bone removal.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, there is a distractor that includes a handle that isadjustable between an insertion position and a distraction position, adatum securement that is attached to the handle and releasably engagablewith a datum, and a tissue engaging portion that is attached to thehandle and movable with respect to the datum securement as the handle isadjusted between the insertion position and the distraction position. Inanother embodiment, the handle includes a first handle portion thatextends from the datum securement and a second handle portion thatextends from the tissue engaging portion. In another embodiment thesecond handle portion is pivotable with respect to the first handleportion. In another embodiment, the first handle portion is releasablyattached to the second handle portion. In a further embodiment, thefirst handle portion is generally planar from the distal end to theproximal end. In another embodiment, the second handle has an angularorientation between a distal end and a proximal end. In anotherembodiment, the second handle portion further comprises a grip portionopposite a tissue engaging portion and an inflection point between thetissue engaging portion and the grip portion wherein the second handleportion is attachable to the first handle portion proximate theinflection point. In another embodiment, the second handle portionincludes a distal portion that is generally parallel the first handleportion when the distractor is in the insertion position and is notgenerally parallel to the first handle portion when the distractor is inthe distraction position. In a further embodiment, a ratchet extendsbetween the first handle portion and the second handle portion. Inanother embodiment, the ratchet is positioned at the proximal end of thedistractor. In another embodiment, the ratchet is pivotally attached tothe first handle portion. In another embodiment, the ratchet isdetachable from the second handle portion. In another embodiment, thetissue engaging portion includes a paddle pivotally attached to thesecond handle portion. In another embodiment, the paddle is generallyparallel with the handle in the insertion position. In anotherembodiment, the paddle is generally flush with the handle in theinsertion position. In another embodiment, at least a portion of thepaddle is sized and configured to extend over the datum and between aplurality of projections extending from the datum. In anotherembodiment, a proximal end of the paddle is heavier than the distal endof the paddle. In another embodiment, the datum securement includes anabutment member, the abutment member engagable with the datum andmovable from a secured position to a released position. In a furtherembodiment, a datum lock is configured to move the datum datumsecurement from a secured position to a released position. In anotherembodiment, the datum lock includes a rotatable nut that threadablyengages a shaft extending from the datum securement. In anotherembodiment, the handle further comprises a grip portion having aplurality of indentations separated by columns that are orientedperpendicular to a longitudinal axis of the handle.

In one embodiment, there is a tissue resection guide for use with adatum that includes a base releasably engagable with the datum andhaving a first frame fixed relative to the base and the first framehaving at least one integral first guide path sized and configured to atleast partially capture and guide a first tissue resection tool relativeto the first frame. In another embodiment, the base further includes asecond frame fixed relative to the base, the second frame having atleast one integral second guide path sized and configured to at leastpartially capture and guide a second tissue resection tool relative tothe first frame. In another embodiment, the second frame has an at leastpartially open sidewall. In another embodiment, the at least partiallyopen sidewall includes two tapered and spaced apart side wall segments.In another embodiment, the base has a bottom surface engagable with thedatum and a top surface opposite the bottom surface of the base, the atleast one second guide path is at least partially closed proximate thetop surface of the base and substantially open proximate the bottomsurface of the base. In another embodiment, the at least one first guidepath is raised upwardly further from the base in a direction generallynormal to the top of the base than the at least one second guide path.In another embodiment, at least one of the first and second frames areangled inwardly toward the base. In another embodiment, the second framehas an angle of inclination relative to the base greater than an angleof inclination between the base and the first frame. In anotherembodiment, the at least one second guide path and a surface of thedatum define a resection plane when the base is engaged with the datum.In another embodiment, the at least one guide path includes an enlargedend. In another embodiment, at least two enlarged ends are on oppositelateral sides of the first frame. In another embodiment, the at leastone first guide path includes two substantially parallel longitudinalguide paths. In one embodiment, the two substantially parallellongitudinal guide paths has a longitudinal axis and an enlarged end,and wherein the longitudinal axes of adjacent longitudinal guide pathsare spaced apart from one another by a distance that is less than adiameter of one of the enlarged ends. In one embodiment, the at leastone first guide path and a surface of the datum define a resection planealong which the tissue resection tool is guided when the base is engagedwith the datum. In one embodiment, the base has a bottom surfaceengagable with the datum and a top surface opposite the bottom surfaceof the base, the at least one first guide path is at least partiallyclosed proximate the top surface of the base and substantially openproximate the bottom surface of the base. In one embodiment, the atleast one first guide path is raised upwardly from the top surface basein a direction generally normal to the top of the base. In oneembodiment, the first frame includes at least one viewing windowextending through an outer surface of the first frame. In oneembodiment, the first frame includes an alignment line intersecting withthe at least one viewing window.

In one embodiment there is a datum engagable with at least one tissueresection guide, the datum includes a bottom surface engagable with atissue surface, a first side surface that extends upwardly from thebottom surface to define a first acute angle with the bottom surface, asecond side surface that extends upwardly from the bottom surface todefine a second acute angle with the bottom surface, and a top surfacethat is connected to the first and second side surfaces and has asecurement releasably engagable with the at least one tissue resectionguide. In another embodiment, a surface extends upwardly from the bottomsurface to define a third acute angle with the bottom surface. Inanother embodiment, a fourth side surface extends upwardly from thebottom surface to define an obtuse angle with the bottom surface. Inanother embodiment, a width of the bottom surface measured between thefirst and fourth side surfaces is smaller than the length of the bottomsurface measured between the first and second side surfaces. In anotherembodiment, the third acute angle is smaller than the first and secondacute angles. In another embodiment, a fourth angle between the firstside surface and the third side surface is less than a fifth anglebetween the second side surface and the third side surface. In anotherembodiment, the third side surface is between the first and second sidesurfaces. In another embodiment the top surface is generally parallel tothe bottom surface. In another embodiment, the securement includes athreaded aperture.

In one embodiment, there is a method of implanting a prosthesis betweenfirst and second bones, the method includes the steps of: resectingtissue from the first bone to expose a first resected tissue surface;resecting tissue from the second bone to expose a second resected tissuesurface; attaching a datum to the second resected tissue surface;attaching to the datum a first tissue resection guide configured toguide the first tissue resection tool; further resecting tissue from thesecond bone with the first tissue resection tool while the first tissueresection tool is guided by the first tissue resection guide to expose athird resected tissue surface; and placing the prosthesis in contactwith the first and second resected tissue surfaces to operativelyconnect the first and second bones. In a further embodiment, the methodincludes attaching a second tissue resection guide on the datum; andforming a fourth resected tissue surface by further resecting tissuefrom the second bone using the second tissue resection guide to guide asecond tissue resection tool. In another embodiment, the third resectedtissue surface is adjacent to a first side of the datum and the fourthresected tissue surface is adjacent to a second side of the datum. Inanother embodiment, the third resected tissue surface is generallyaligned with the first side of the datum and the fourth resected tissuesurface is generally aligned with the second side of the datum. Inanother embodiment, resecting the first bone further includes applying asecond tissue resection tool to the first bone along a second tissueresection guide fixed relative to the first bone. In a furtherembodiment, the method includes determining the position of the secondtissue resection guide based upon the position of a spacer guideattached to the second tissue resection guide. In a further embodiment,the method includes fixing the second bone relative to the first boneprior to resecting tissue from the second bone to expose the secondresected tissue surface. In a further embodiment, the method includesaligning a feature of the first tissue resection tool with a feature ofthe first tissue resection guide to achieve a predetermined resectiondepth. In a further embodiment, the method includes positioning thedatum on the second resected tissue surface with a distractor; andmoving the first bone away from the second bone with the distractor. Ina further embodiment, the method includes placing a window trial overthe second resected tissue surface and third resected tissue surfaces toevaluate the size and shape of the second resected tissue surface andthe third resected tissue surface. In a further embodiment, the methodincludes positioning a barrel cut guide against the first resectedtissue surface; inserting a drill bit through an aperture in the barrelcut guide; and drilling a cavity into the first bone using the drillbit, the cavity receiving a portion of the prosthesis. In anotherembodiment, the first bone is the tibia and the second bone is thetalus. In another embodiment, the first and second resected tissuesurfaces are comprised of bone.

In one embodiment, there is a tissue resection kit including a datumthat is engagable with a tissue surface, and a first tissue resectionguide having a first base releasably engagable with the datum and havinga first frame fixed relative to the first base, the first frame havingat least one integral first guide path sized and configured to at leastpartially capture and guide a first tissue resection tool relative tothe first frame. In another embodiment, the first base includes a thirdframe fixed relative to the first base, the third frame having at leastone integral third guide path sized and configured to at least partiallycapture and guide a third tissue resection tool relative to the firstframe. In another embodiment, the at least one first guide path and asurface of the datum define a resection plane along which the tissueresection tool is guided when the first base is engaged with the datum.In a further embodiment, the tissue resection kit includes a secondtissue resection guide having a second base releasably engagable withthe datum and having a second frame fixed relative to the second base,the second frame having at least one integral second guide path sizedand configured to at least partially capture and guide a second tissueresection tool relative to the second frame. In a further embodiment,the tissue resection kit includes a distractor releasably engagable withthe datum. In a further embodiment, the tissue resection kit includes awindow trial engagable with the tissue surface, the window trial havingthe general shape and configuration of a prosthesis and having one ormore apertures for viewing the tissue surface.

In one embodiment there is an alignment guide for attaching one orresection guides to a bone and includes an elongated member having afirst end, a second end and a longitudinal axis extending between thefirst and second ends, a first securement proximate the first end andconfigured to releasably connect with the bone, an attachment blockproximate the second end and having a second securement configured toreleasably connect to the bone and a grip tool releasably connectable tothe attachment block and generally perpendicular to the attachment blockin an engaged position. In a further embodiment, the alignment guideincludes an elongated alignment member attached to the elongated memberand spaced laterally from and generally parallel to the longitudinalaxis.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofembodiments of the surgical instrumentation and methods of use forimplanting a total joint replacement will be better understood when readin conjunction with the appended drawings of exemplary embodiments. Itshould be understood, however, that the invention is not limited to theprecise arrangements and instrumentalities shown.

In the drawings:

FIG. 1 is a perspective view of a total joint replacement implantedbetween first and second bones;

FIG. 2 is a side, partially cross-section, partially transparent sideview of the implanted total joint replacement of FIG. 1;

FIG. 3 is a perspective view of an alignment guide in accordance with anexemplary embodiment of the present invention;

FIG. 4 is a top view of the alignment guide shown in FIG. 3 with thepositioning tool removed;

FIG. 5 is a perspective view of a first tissue resection guide inaccordance with an exemplary embodiment of the present invention;

FIG. 6 is a perspective view of a spacer guide in accordance with anexemplary embodiment of the present invention;

FIG. 7 is a perspective view of a second tissue resection guide inaccordance with an exemplary embodiment of the present invention;

FIG. 8 is a perspective view of the second tissue resection guide shownin FIG. 7 having a tab extension;

FIG. 9A is a perspective view of a datum in accordance with an exemplaryembodiment of the present invention;

FIG. 9B is a top plan view of the datum shown in FIG. 9A;

FIG. 9C is a bottom perspective front view of the datum shown in FIG.9A.

FIG. 10A is a perspective view of a distractor in accordance with anexemplary embodiment of the present invention shown in an insertionposition and securing the datum of FIG. 9A;

FIG. 10B is an enlarged view of a datum lock of the distractor shown inFIG. 10A;

FIG. 10C an enlarged top view of a paddle of the distractor shown inFIG. 10A being pivoted for demonstrative purposes;

FIG. 10D a perspective view of the distractor shown in FIG. 10A with theupper handle removed, the ratchet pivoted downwardly and the datum shownin phantom;

FIG. 10E is a bottom plan view of the distractor shown in FIG. 10D;

FIG. 11A is a top plan view of a third tissue resection guide inaccordance with an exemplary embodiment of the present invention;

FIG. 11B is a bottom perspective view of the third tissue resectionguide shown in FIG. 11A;

FIG. 12A is a top plan view of a fourth tissue resection guide inaccordance with an exemplary embodiment of the present invention;

FIG. 12B is a front elevational view of the fourth tissue resectionguide shown in FIG. 12A;

FIG. 12C is a side elevational view of the fourth tissue resection guideshown in FIG. 12A;

FIG. 13 is a perspective view of a window trial in accordance with anexemplary embodiment of the present invention;

FIG. 14 is a perspective view of a barrel cut guide in accordance withan exemplary embodiment of the present invention;

FIG. 15 is a perspective view of a fin cutter in accordance with anexemplary embodiment of the present invention.

FIG. 16 is a perspective view of an incision in an ankle exposing theankle joint;

FIG. 17 a side elevational view of a lower leg of a patient with thealignment guide shown in FIG. 3 attached to the first bone;

FIG. 18 is a top plan view of the alignment guide shown in FIG. 4attached to the first bone and outlining two resection paths;

FIG. 19 is a top plan view of the alignment guide shown in FIG. 18 withthe first tissue resection guide of FIG. 5 attached;

FIG. 20 is a side view of the alignment guide and first tissue resectionguide shown in FIG. 19 with the spacer guide of FIG. 6 attached;

FIG. 21 is a side view of the alignment guide shown if FIG. 4 with thesecond tissue resection guide of FIG. 8 attached to the alignment guideand the second bone;

FIG. 22 is a side view of a space evaluator positioned between the firstand second resected tissue surfaces;

FIG. 23 is a perspective view of a sizer on top of the second resectedtissue surface;

FIG. 24 is a perspective view of the distractor shown in FIG. 10A in theinsertion position;

FIG. 25 is a perspective view of the distractor shown in FIG. 10A in thedistracted position;

FIG. 26 is a perspective view of the datum attached to the secondresected tissue surface;

FIG. 27 is a rear perspective view of a second tissue resection toolbeing guided by the third tissue resection guide shown in FIG. 11A;

FIG. 28 is a side elevational view of a third tissue resection toolbeing guided by the third tissue resection guide shown in FIG. 11A;

FIG. 29 is a front perspective view of the second tissue resection toolbeing guided by the third tissue resection guide shown in FIG. 11A;

FIG. 30 is a perspective view of the second resected tissue surfaceafter use of the second and third tissue resection guides shown in FIGS.8 and 11A respectively;

FIG. 31 is a perspective view of a fourth tissue resection tool beingguided by the fourth tissue resection guide shown in FIG. 12A;

FIG. 32 is a perspective view of the fourth tissue resection guide shownin FIG. 31 showing the resected surface created by the fourth tissueresection tool;

FIG. 33 is a perspective view of the resected tissue surfaces after useof the second, third and fourth tissue resection guides shown in FIGS.8, 11A and 12A respectively;

FIG. 34 is a perspective view of the window trial shown in FIG. 13 onthe resected tissue surfaces shown in FIG. 33; and

FIG. 35 is a side elevational partially transparent view of the barrelcut guide shown in FIG. 14 and the window trial on the resected tissuesurfaces shown in FIG. 34.

DETAILED DESCRIPTION

Referring to the drawings in detail, wherein like reference numeralsindicate like elements throughout, there is shown in FIGS. 1-35 surgicalinstrumentation and methods of use for installing a prosthesis orendoprosthesis such as, for example, a total joint replacement,generally designated 10, between first and second bones 12, 14, inaccordance with exemplary embodiments of the present invention.

Referring to FIGS. 1 and 2, in one embodiment, the total jointreplacement 10 may be an ankle joint and the first and second bones 12,14 may be the tibia and the talus respectively. A third bone 16, such asthe fibula, may also contact the total joint replacement 10. In oneembodiment, the total joint replacement 10 is a total ankle replacementsuch as described in U.S. Pat. No. 6,852,130 which is herebyincorporated by reference in its entirety, and is commercially known asthe S.T.A.R.® or the Scandinavian Total Ankle Replacement System.However, the present invention may be used for resecting tissue surfacesin implanting any prosthetic device.

In one an embodiment, the total joint replacement 10 includes a firstendoprosthetic component 18 that engages the first bone 12 and a secondendoprosthetic component 20 that engages the second bone 14. In oneembodiment, the second endoprosthetic component 20 includes projections20 a that are slidable into resected cavities 12 a in the first bone 12.In one embodiment, the total joint replacement 10 further includes amiddle endoprosthetic component 22 that is positioned between the firstand second endoprosthetic components 18, 20 to provide a three piecetotal joint replacement 10. The first endoprosthetic component 18 mayinclude a rib 18 a for preventing lateral movement of the middleendoprosthetic component 22 relative to the first endoprostheticcomponent 18. The first endoprosthetic component 18 may also include afin 18 b for extending into the second bone 14 and stabilizing the totaljoint replacement 10 relative to the second bone 14.

In one embodiment, the first endoprosthetic component 18 has theapproximate dimensions set forth in Table 1 below.

TABLE 1 First Endoprosthetic Component Dimensions (in mm) XX - SmallX-Small Small Medium Large ML Dimension (Width) 28 30 34 36 38 APDimension (Depth) 29 31 35 35 35

In one embodiment the second endoprosthetic component 20 has theapproximate dimensions set forth in Table 2 below.

TABLE 2 Second Endoprosthetic Component Dimensions (in mm) X-Small SmallMedium Large X-Large ML Dimension (Width) 30 32 32.5 33 33.5 APDimension (Depth) 30 30 35 40 45

Though further description herein of the first and second bones 12, 14may refer to the tibia 12 and talus 14 and respective anatomicaldirections, the instrumentation and methods disclosed herein are notlimited to the tibia 12, talus 14, fibula 16 and respective anatomicaldirections. The first, second and third bones 12, 14, 16 as disclosedherein may be any jointed bones such as the elbow, knee, shoulder orknuckle or a portion thereof that are prepared for the installation orimplantation of the total joint replacement 10 or an endoprostheticcomponent from any direction. The various instrumentation and methodsdescribed below may be used in different orientations depending on theapplication and reference to anatomical orientation as used herein isfor exemplary purposes. Additionally, though a left ankle 24 and foot 26are shown and described, the various instrumentation and methodsdescribed below may be used in conjunction with and/or oriented for usewith the right ankle (not shown or illustrated) or another applicablejoint.

Alignment Guide

Referring to the embodiment of FIG. 3, an alignment guide 30 may be usedto assist in implanting the total joint replacement 10. The alignmentguide 30 may be used to orient one or more instruments, such as firstand second tissue resection guides 66, 90 relative to the first bone 12as described further below. The alignment guide 30 includes a first end30 a and a second end 30 d. The alignment guide 30 may include a firstbody 30 b proximate the first end 30 a and a second body 30 c proximatethe second end 30 d. In one embodiment, the first and second bodies 30b, 30 c are each comprised of one or more generally cylindricalelongated rods. However, the first and second bodies 30 b, 30 c may haveany suitable configuration and shape such as a tube that encloses a leg84 (see FIG. 17). The alignment guide 30 may include a pin receiver 32.The pin receiver 32 may be proximate the first end 30 a. The pinreceiver 32 may include a slot 32 a and/or a plurality of apertures (notshown) for receiving one or more pins 34 at a plurality of lateralpositions. The pin receiver 32 may also move up and down the pin 34 asdescribed further below. In one embodiment, the pin receiver 32 includesa first securement 36 such as a manually adjustable screw that securesthe pin receiver 32 to the pin 34 and prevents the alignment guide 30from moving relative to the pin 32. In one embodiment, the pin 32 is aself drilling pin and is approximately 3.2 mm in diameter. However, thepin 32 may have any suitable configuration and size.

An attachment block 38 may be connected to the second body 30 c of thealignment guide 30. The attachment block 38 may be configured to securethe second end 30 d of the alignment guide 30 to the first bone 12. Theattachment block 38 may serve as a datum for one or more resections asdescribed further below. In one embodiment, the second body 30 c of thealignment guide 30 is telescopically connected to the first body 30 b ofthe alignment guide 30. In one an embodiment, the second body 30 c ofthe alignment guide 30 may be fixed with respect to the first body 30 aof the alignment guide 30 through use of a second securement 40. Thesecond securement 40 may be a manually adjustable screw. Alternatively,the length of the alignment guide 30 may be fixed and the attachmentblock 38 may adjust relative to the alignment guide 30. The attachmentblock 38 may include one or more apertures 38 a each for receiving a pin42. In one embodiment, the pins 42 may be inserted through theattachment block 38 at an angle such as an oblique angle as shown inFIG. 3. The pins 42 may be comprised of Kirschner or K-wire. In oneembodiment the pins are approximately 2.4 mm in diameter. However, thepins 42 may have any suitable configuration and diameter. Though thesame reference number is used for the additional pins 42 describedbelow, the additional pins 42 described below may be generally identicalor different than the pins 42 used to secure the attachment block 38relative to the first bone 12.

The attachment block 38 may include one or more space adjustments 48that may be threadably received in a respective aperture 38 b. One ormore space adjustments 48, such as a manually adjustable screw, may beprovided to stabilize the attachment block 38 relative to the first bone12. The space adjustment 48 may alternatively or in addition help toposition the attachment block 38 a distance normal to the first bone 12by extending below the attachment block 38 an adjustable distance.

An alignment rod 44 is optionally spaced laterally from the alignmentguide 30 and is configured to be positionable alongside the first bone12. In one embodiment, the alignment rod 44 is generally parallel withthe first body 30 b of the alignment guide 30. An X-ray imageintensifier, such as a C-arm or other imaging device (not shown), may beused to align the alignment rod 44 generally parallel with a feature 12f of the first bone 12. In one embodiment the alignment rod 44 isaligned to be generally parallel to the longitudinal axis of the firstbone 12. The alignment rod 44 may be attached to the first body 30 b ofthe alignment guide 30 by an arm 44 a. A grip member or positioning tool46 such as a T-grip may releaseably connect or attach to the attachmentblock 38 to assist in orienting the attachment block 38 relative to thefirst bone 12. In one embodiment, the grip member 46 is generallyperpendicular to a longitudinal axis of the alignment guide 30 in anengaged position.

Referring to the embodiment of FIG. 4, the attachment block 38 mayinclude a first positioning block 50. In one embodiment, the attachmentblock 38 is fixed relative to the first bone 12 and the firstpositioning block 50 is movable relative to the attachment block 38. Inone embodiment, the first positioning block 50 is adjustable relative tothe attachment block 38 in first and second directions, e.g. superiorand inferior anatomical directions, that are generally parallel to thelength of the alignment guide 30. The attachment block 38 may include afirst key adjustment 52 that may be configured to set the distancebetween the attachment block 38 and the first positioning block 50. Inone embodiment, the first key adjustment 52 engages a first rack 54 thatextends from the first positioning block 50 and into the attachmentblock 38. Alternatively, the first rack 54 may extend from theattachment block 38 and extend into the first positioning block 50. Thefirst key adjustment 52 may be turned using a tool such as a gear key orscrew driver (not shown). Alternatively, the key adjustment 52 may be amanually adjustable screw. The attachment block 38 optionally includes afirst position lock 56 that releasably fixes the distance between theattachment block 38 and the first positioning block 50. In oneembodiment, the first position lock 56 is a set screw. However, thefirst position lock 56 may be any locking device such as projectionextending into the first key adjustment 52.

The first positioning block 50 may include one or more pin apertures 50a each for receiving a pin 42 that extends into the first bone 12. Inone embodiment, the first positioning block 50 includes a firstplurality of pin apertures 50 a. The first plurality of apertures 50 amay be provided to move the first positioning block 50 a predetermineddistance with respect to the one or more pins 42 for measuringadditional resection of the first bone 12 if necessary as describedfurther below. The first plurality of pin apertures 50 a may include afirst pin aperture 50 b spaced a predetermined distance from a secondpin aperture 50 c in a direction generally parallel to the length of thealignment guide 30, e.g. in an inferior anatomical direction. In oneembodiment, a third pin aperture 50 d is spaced a predetermined distancefrom the second pin aperture 50 c in a direction generally parallel tothe length of the alignment guide 30, e.g. in an inferior anatomicaldirection. The first plurality of pin apertures 50 a may includeadditional apertures 50 a.

In one embodiment, the first and second pin apertures 50 b, 50 c arespaced from each other a distance equal to the space between the secondand third pin apertures 50 c, 50 d. In one embodiment, the firstpositioning block 50 includes a second plurality of pin apertures 50 a′.The second plurality of pin apertures 50 a′ may include first, secondand third pin apertures 50 b′, 50 c′, 50 d′ that each correspond inplacement along the first positioning block to respective first, secondand third pin apertures 50 b, 50 c, 50 d of the first plurality of pinapertures 50 a. In one embodiment, the predetermined intervals betweenadjacent pin apertures 50 a, 50 a′ are each generally 0.5 mm togenerally 5 mm such that the positioning block may be moved relative tothe pins 42 the predetermined distance and 0.5 mm to 5 mm of additionaltissue can be resected from the end of the first bone 12 in one or moreadditional resections. In one embodiment, the predetermined intervalsbetween adjacent pin apertures 50 a are approximately 2 mm.Alternatively, the first positioning block 50 is movable relative to thepins 42 such as having expanding and contracting ends (not shown) or thepositioning block 50 may include a slot (not shown) that releasablyengages one or more pins 42 to adjust the position of the firstpositioning block 50 relative to the first bone 12.

The attachment block 38 may include a second positioning block 58 thatis movable relative to the portion of the attachment block 38 fixedrelative to the first bone 12. In one embodiment, the second positioningblock 58 is movable relative to the first positioning block 50.Alternatively, the first and second positioning blocks 50, 58 areintegral. The second positioning block 58 may be adjustable relative tothe attachment block 38 in third and fourth directions, e.g. lateral andmedial anatomical directions, that may be generally perpendicular to thelength of the alignment guide 30. The first positioning block 50 mayinclude a second key adjustment 60 that is used to adjust the positionof the second positioning block 58 relative to the attachment block 38.

In one embodiment, the second key adjustment 60 engages a second rack(not visible) that extends along the second positioning block 58. Thesecond key adjustment 60 may be turned using a tool such as a gear keyor screw driver (not shown) to move the second positioning block 58relative to the first positioning block 50. Alternatively, the secondkey adjustment 60 may be a manually adjustable screw. The second rackmay be alternatively attached to the first positioning block 50. Thefirst positioning block 50 optionally includes a second position lock 62that releasably fixes the lateral alignment between the secondpositioning block 58 and the first positioning block 50 to preventunintentional movement between the first and second positioning blocks50, 58. In one embodiment, the second position lock 62 is a set screw.However, the second position lock 62 may be any locking device such asprojection extending into the second key adjustment 60.

In one embodiment, the second positioning block 58 includes first andsecond grooves 58 a, 58 b on opposing lateral sides of the secondpositioning block 58. The first and second grooves 58 a, 58 b may bereceive and mate with the positioning tool 46 and additionalinstrumentation as described below to prevent movement between thesecond positioning block 58 and the positioning tool 46 or additionalinstrumentation. The positioning tool 46 may be used to assist inpositioning the attachment block 38 relative to the first bone 12. Thesecond positioning block 58 may include a threaded aperture 58 d forsecuring to additional instrumentation as described below. The secondpositioning block 58 may include one or more apertures 58 c each forviewing the first bone 12 during positioning of the attachment block 38using a C-arm or other imaging device. In one embodiment, the apertures58 c show up on the imaging device as circular if the attachment block38 is correctly positioned with respect to the first bone 12 and ovalshaped if the attachment block 38 is misaligned with respect to thefirst bone 12. The apertures 58 c may generally align with where thecavities 12 a (FIG. 1) are to be drilled.

First Tissue Resection Guide

Referring to the embodiment of FIG. 5, a first tissue resection guide 66may be provided for resecting the first bone 12 and exposing a firstresected tissue surface 100 as described below. In one embodiment, thefirst resected tissue surface 100 is bone tissue. In alternativeembodiments, the first resected tissue surface 100 is another tissuesuch as cartilage and/or a combination of different tissue. The firsttissue resection guide 66 may removably attach to the second positioningblock 58. The first tissue resection guide 66 may include a fastener 68that releasably attaches the first tissue resection guide 66 to theaperture 58 d (see FIG. 4) in the second positioning block 58. In oneembodiment, the fastener 68 is an Allen screw. However, the fastener 68may be any attachment device such as a snap or magnet. The first tissueresection guide 66 may include first and second projections 66 a, 66 b(see FIGS. 7 and 8 for the second projection 66 b) that may be receivedin the first and second grooves 58 a, 58 b, respectively of the secondpositioning block 58. The first and second projections 66 a, 66 b mayhelp to prevent the first tissue resection guide 66 from moving orrotating with respect to the second positioning block 58.

In one embodiment, the first tissue resection guide 66 includes a firstguide path 70 for resecting the first bone 12. The first guide path 70may be a slot 70 a such that the guide path captures a tissue resectiontool such as a blade (not shown). The slot 70 a may be generallyrectangular and oriented such the blade is captured and guided in adirection generally perpendicular to the length of the first bone 12,e.g. the medial and lateral anatomical directions. The blade may beguided at a slight angle relative the longitudinal axis of the firstbone 12 as described further below. An end surface 58 e of the secondpositioning block 58 (see FIG. 4) and the first guide path 70 may definea resection plane. In an alternative embodiment, the first guide path 70is open toward one lateral side (not shown) such that the first tissueresection tool is guided on only one side. The slot 70 a may include pinapertures 70 b, 70 c at the ends of the slot 70 a for inserting pins 42(not shown). The pins 42 may be used to protect features of the firstand third bones 12, 16 such as medial and lateral malleolus 12 e, 16 a.The first bone 12 may be cut until the first tissue resection toolcontacts the pins 42. The pins 42 may prevent over or notched cuts inthe first bone 12.

In one embodiment, the first tissue resection guide 66 includes a secondguide path 72. The second guide path 72 is optionally provided to guidethe tissue resection tool for a second resection. The second guide path72 may be generally perpendicular to the blade guard 70. In oneembodiment, the second guide path 72 is open toward one lateral side anddefines only one side of a resection plane. In an alternativeembodiment, the second guide path 72 is closed similar to the firstguide path 70 to capture the blade on two opposing sides (not shown).

The first tissue resection guide 66 may include indicia 74 indicatingwhich foot (i.e. left or right) 26 the first tissue resection guide 66is to be used on. The indicia 74 may also, or in the alternative,indicate a size of the first tissue resection guide 66. The first tissueresection guide 66 may include an indent 66 c on each lateral side ofthe first tissue resection guide 66 to aide in gripping the first tissueresection guide 66 during insertion and removal from the second positingblock 58.

Spacer Guide

Referring to the embodiment of FIG. 6, a spacer guide 78 may be providedfor positioning the first and second positioning blocks 50, 58 relativeto the attachment block 38 and a feature 12 c of the first bone 12(FIGS. 17-20). Because the attachment block 38 may be attached to thefirst bone 12 proximate the feature 12 c, the spacer guide 78 may beused to adjust the first and second positioning blocks 50, 58 andposition the end surface 58 e of the second positioning block 58 in theappropriate position. The spacer guide 78 may be used in conjunctionwith a C-arm or other imaging device to position the end surface 58 e ofthe second positioning block 58 a predetermined distance from thefeature 12 c of the first bone 12. In one embodiment, the feature 12 cis a superior aspect of the tibial plafond of the tibia (see FIG. 20).

The spacer guide 78 may include an extension arm 80 extending downwardlyfrom a body 78 a of the spacer guide 78. In one embodiment, theextension arm 80 is curved inwardly toward the body 78 a during use ofthe spacer guide 78 such that the extension arm 80 curves around theoutside of the patient's anatomy, e.g. leg 84. However, the extensionarm 80 may be straight or outwardly curved and have any shape.

The spacer guide 78 may include a projection or mount 82 extendingdownwardly from the body 78 a and spaced laterally from the extensionarm 80. The mount 82 may be configured to snugly fit within the slot 70a of the first guide path 70. The body 78 a optionally includes a grip78 b such as an aperture extending through the body 78 a to aid ingrasping the spacer guide 78 between two fingers. The extension arm 80,the body 78 a and the mount 82 may be generally planar and parallel toone another.

The extension arm 78 may include one or more projections 86 extendingfrom the extension arm 80 and spaced a predetermined distance from themount 82 in order to measure the distance from the slot 70 a of thefirst guide path 70. In one embodiment, the projections 86 are pins. Theprojections 86 may extend through the extension arm 80 such that theprojections 86 extend from either side of the extension arm 78 allowingthe spacer guide 78 to be used on either lateral side of the ankle 24.In one embodiment, the predetermined distance, i.e. the length of eachprojection from each side of the extension arm 80 is approximately 1 mmto approximately 10 mm. In one embodiment, the projections 86 extendapproximately 5 mm from the extension arm 80. In one embodiment, thereare 6-8 projections 86. However, their may be any number of projections86 having any configuration. The projections 86 may each include aplurality of distance markings such as ribs or include projections 86having different lengths so that multiple predetermined distances can beascertained using a single spacer guide 78. Alternatively, the extensionarm 80 and/or body 78 a may be curved or spaced from the mount 82 in thenormal direction from the body 78 a such that the extension arm 80 isspaced from the mount 82 the predetermined distance in the normaldirection from the body 78 a without the need for projections 86. Theextension arm 80 may alternatively be adjustable relative to the mount82 such that the predetermined distance may be altered by adjusting afeature or adjusting the orientation of the extension arm 80 relative tothe body 78 a. The extension arm 80 may alternatively have a thicknessequal to the predetermined distance from the mount 82 for measuring thepredetermined distance.

Second Tissue Resection Guide

Referring to the embodiment of FIG. 7, a second tissue resection guide90 may be provided to resect tissue from the second bone 14 using, forexample, the first tissue resection tool (not shown). The second tissueresection guide 90 may be mounted to the second bone 14 relative to theplacement of the attachment block 38. In one embodiment, the secondtissue resection guide 90 is configured to mount over the first tissueresection guide 66 such that the second bone 14 is resected relative tothe first resected tissue surface 100 (FIG. 21). The second tissueresection guide 90 may include a mount 92 for securing the second tissueresection guide 90 to first tissue resection guide 66. The mount 92 maybe configured to receive the fastener 68 used to secure the first tissueresection guide 66 to the second positioning block 58.

In one embodiment, a tab 98 extends downwardly from the second tissueresection guide 90 to contact the first bone 12. The tab 98 may contactthe first resected tissue surface 100 of the first bone 12 to helpstabilize the second tissue resection guide 90 relative to the firstbone 12. In an alternative embodiment of the second tissue resectionguide 90, the second tissue resection guide 90 includes an integralcomponent that is shaped and configured similar to the first tissueresection guide 66 such that after using the first tissue resectionguide 90, the first tissue resection guide 66 is removed from the secondpositioning block 58 and the second tissue resection guide 90 with theintegral first tissue resection guide 66 is mountable directly to thesecond positioning block 58.

The second tissue resection guide 90 may include a guide path 94 forguiding and capturing a tissue resection tool such as the first tissueresection tool, e.g. a blade (not shown). The second tissue resectionguide 90 may be configured to guide a tissue resection tool that isdifferent or the same from the tissue resection tool used with the firsttissue resection guide 66. The first tissue resection tool may be usedwith the second tissue resection guide 90 to expose a resected or secondsurface 104 (see FIG. 22) of the second bone 14. In one embodiment, thesecond resected tissue surface 104 is bone. In alternative embodiments,the second resected tissue surface 104 is another tissue such ascartilage and/or a combination of different tissue.

In one embodiment, the second tissue resection guide 90 may beconfigured such that one side of the guide path 94 is generally flush orparallel with an outer end 66 d (FIG. 5) of the first tissue resectionguide 66 such that the guide path 94 and the outer end 66 d of the firsttissue resection guide 66 define a resection plane. In one embodiment,the first and second tissue resection guides 66, 90 are configured sothat when engaged with each other, the guide path 94 is spaced from theslot 70 a of the first guide path 70 a predetermined distance. In oneembodiment, the predetermined distance between the guide path 94 and theslot 70 a of the first guide path 70 is approximately 1 mm toapproximately 8 mm. In one embodiment, the predetermined distancebetween the guide path 94 and the slot 70 a of the first guide path 70is approximately 4 mm. The predetermined distance between the guide path94 and the slot 70 a of the first guide path 70 may be generally equalto the thickness of the first guide path 70. The guide path 94 mayinclude one or more recesses 94 a each for receiving pins (not shown) toadjust the length of the guide path 94 and limit the amount that thesecond bone 14 is resected.

The second tissue resection guide 90 may include one or more pin mounts96. The pin mounts 96 may be used to support pins 42 that secure thesecond tissue resection guide 90 to the second bone 14 (see FIG. 20). Insuch an embodiment, the second bone 14 is held relative to theattachment block 38. In an alternative embodiment, the guide path 94 mayinclude a generally open side such that the first tissue resection toolis only supported or guided on one side.

Referring to the embodiment of FIG. 8, a second tissue resection guide90′ may include a tab extension 102 that extends further downwardly fromthe tab 98′ such that the tab extension 102 is sandwiched between andcontacts both the first resected tissue surface 100 and the not yetresected second bone 14 when initially in place on the first tissueresection guide 66 (see FIG. 21). In one embodiment, the second tissueresection guide 90 is used for normal to tight joints and the secondtissue resection guide 90′ with the tab extension 102′ is used for laxjoints. In one embodiment, the tab extensions 102 are approximately 1 mmto approximately 10 mm thick depending on how lax the joint is. In oneembodiment, the second tissue resection guides 94′ are provided with tabextensions 102 in approximately 2 mm, 4 mm or 6 mm thicknesses. In oneembodiment, the tab extension 102 is generally flat and bulbous shapedsuch that the tab extension 102 sufficiently contacts the first resectedtissue surface 100. However, the tab extension 102 may be any shape suchas rectangular, triangular or square.

Datum

Referring to the embodiment of FIG. 9A-9C, a datum 108 may be providedfor releasably engaging at least one tissue resection guide as describedfurther below. The datum 108 may provide a fixed reference point on thesecond bone 14 to make one or more resections to the second bone 14relative or in reference to the datum 108. The datum 108 may alsoinclude one or more surfaces and/or one or more edges that are alignedwith a feature of the tissue resection guide (e.g. a guide path) to forma resection plane an example of which is described in more detail below.The datum 108 may assist in directly guiding and supporting the variousresection tools. In one embodiment, the datum 108 allows for multipleresections adjacent to the datum using two or more resections guideswhile only attaching one device to the second bone 14, e.g, the datum108.

In one embodiment, the datum 108 is a parallelepiped. However, the datum108 may be generally shaped and sized such that resections guided atleast partially by the datum 108 conform to an upper interior (notshown) of the first endoprosthetic component 18. Though the datum 108may have planar sides, the datum 108 may alternatively have one or morecurved or stepped sides. The shape of the datum 108 may generallycorrespond to the shape required to fully resect an end of the secondbone 14 using a predetermined number of generally planar resectionplanes. In one embodiment, the datum 108 includes four generally planarresection planes. The use of the datum 108 may help to minimize theamount of tissue that is resected from the second bone 14 by reducingrecutting, reshaping and over resection caused by free-hand cutting,miss-measurements, measuring off of other cuts and/or misplacement ofresection guides.

In one embodiment, the datum 108 includes first, second, third and forthsides 108 a, 108 b, 108 c, 108 e. In one embodiment, a bottom 108 d ofthe datum 108 is sized and configured to contact a tissue surface (e.g.,the second resected tissue surface 104). In one embodiment, the datum108 has at least one side (e.g., one of sides 108 a, 108 b, 108 c, 108e) that is generally in-line or parallel to a resected tissue surfacesuch as a tissue surface (e.g. one of surfaces 104 a, 104 b, 104 c, 104d) such as in a manner described below after the resections to thesecond bone 14 are made. The first second and third sides 108 a, 108 b,108 c of the datum 108 may each be angled inwardly such that they eachextend at an acute angle from the base or bottom 108 d (FIG. 9C). In oneembodiment, the top of the fourth side 108 e may extend outwardly suchthat the fourth side 108 e extends at an obtuse angle from the bottom108 d. The second and third sides 108 b, 108 c may be angled inwardlytoward each other proximate the first side 108 a about an axisperpendicular to the bottom 108 d such that the second and third sides108 b, 108 c each extend from the fourth side 108 e at an acute anglemeasured on a plane parallel to the bottom 108 d. In one embodiment, thefirst side 108 a is generally ninety degrees from the fourth side 108 eas measured on a plane parallel to the bottom 108 d. In one embodiment,the third side 108 c is angled inwardly proximate the first side 108 aabout an axis perpendicular to the bottom 108 d. An angle of inclinationdefined by the intersection of the third side 108 c and a plane normalto the bottom 108 d may be greater than an angle of inclination definedby the intersection of the second side 108 b and a plane normal to thebottom 108 d as illustrated in FIG. 9B. At least one side 108 a, 108 b,108 c, 108 e of the datum 108 may be sized and configured to at leastpartially contact and guide a tissue resection tool as described furtherbelow. In one embodiment, the first, second, third and fourth sides 108a, 108 b, 108 c, 108 e of the datum 108 are posterior, medial, lateraland anterior sides respectively.

The datum 108 optionally includes a datum mount 110. The datum mount 110may include a threaded aperture 110 a. The datum mount 110 may include arecessed section 110 b for further engaging at least one tissueresection guide and for receiving a datum securement 122 of a distractor120 (see, e.g., FIG. 10D). The recessed section 110 b may have agenerally cube-like shape. However, the recessed section 110 b may haveany shape such as pyramid, spherical-like or approximations thereof.

The datum 108 may include at least one pin aperture 112 for receiving apin 42 or a shoulder pin 114. The pin aperture 112 may include ashoulder 112 a to limit depth of the shoulder pins 114 (FIG. 25). Thepins 114 may be received at an angle relative to the bottom 108 d suchthat the pins 114 extend upwardly from the datum 108 toward the fourthside 108 e of the datum 108. In one embodiment, the datum 114 includes apair of pin apertures 120 spaced on medial/lateral sides of the datummount 110 such that when pinned to the second resected tissue surface104, the datum 108 does not rotate relative to the second resectedtissue surface 104.

The datum 108 may include indicia 116 such as a colored polymeric plugthat indicates the size and/or shape of the datum 108. In oneembodiment, the indicia 116 is positioned on a non-tissue contactingsurface. In one embodiment, the indicia 116 is located on a surfaceopposite a surface that is a tissue contacting surface such as, forexample, the bottom 108 in the embodiment illustrated in FIG. 9C.

Distractor

FIGS. 10A-10C illustrates one embodiment of a distractor 120. Thedistractor 120 may be sized and configured to place, orient and/orinsert the datum 108 onto a tissue surface, e.g. the second resectedtissue surface 104. The distractor 120 may additionally be used todistract or separate the first resected tissue surface 100 from thesecond resected tissue surface 104 and provide sufficient space to placethe datum 108 and attach resection guides thereto. The distractor 120may include a handle 129 and a datum securement 122 and a tissueengaging portion 134 attached to the handle 129. At least a portion ofthe handle 129 may extend along a handle axis 120 a. In one embodiment,the handle 129 includes a first or lower handle 130 and a second orupper handle 136.

The datum securement 122 may be configured to releasably engage thedatum 108. The datum securement 122 may releasably engage the datum 108in an insertion position (FIG. 10A) and or during positioning of thedatum 108 on the second resected tissue surface 104 (FIGS. 24 and 25).In one embodiment, the datum securement 122 includes at least oneprojection 122 a. The projection 122 a may be oriented to project fromthe datum securement 122 at an angle relative to the axis 120 a.Projections 122 a may be sized, configured and oriented to extend intothe datum mount 110 of the datum 108. However, the datum securement 122may include any suitable device for releasably engaging or securing thedatum 108 such as a threaded attachment or a magnet.

In one embodiment, the distractor 120 includes an abutment member 124proximate the datum securement 122. The abutment member 124 may be forkshaped such that the datum 108 is engaged by ends 124 a on either sidesof the projection 122 a to provide at least three points of contact withthe datum 108 such that the datum 108 is securely held and does not moverelative to the distractor 120. However, the abutment member 124 mayhave any suitable shape including one or more surface or point ofcontact end 124 a. The ends 124 a of the abutment member 124 may beslanted or otherwise shaped and configured to be generally parallel tothe fourth side 108 e of the datum 108. The abutment member 124 may beslidable relative to a lower handle 130 extending from the datumsecurement 122. The abutment member 124 may be slid toward the datumprojection 122 a to pinch the datum 108 between the datum projection 122a and the abutment member 124. Alternatively, the datum projection 122 amay be moved relative to the abutment member 124. The abutment member124 may have a recessed or stepped distal bottom surface 124 b (FIG.10D) such that the abutment member 124 is generally flush or parallelwith the bottom surface 108 d of the datum 108. The remainder of theabutment member 124 may be thicker than the distal bottom surface 124 bto strengthen the abutment member 124.

In one embodiment, the abutment member 124 includes a datum lock 126configured to move the datum datum securement 124 from a securedposition to a released position. The datum lock 126 may include arotatable nut 126 a that threadably engages a shaft 124 c. In oneembodiment, the shaft 126 c is integral with the abutment member 124. Inan alternative embodiment, the shaft 124 c is integral with the nut 126a and the threaded shaft 124 c extends into the abutment member 124. Thedatum securement 122 may include a stop 128 (FIG. 10E) that engages withthe abutment member 124 when the datum 108 has been secured with thedistractor 120 to prevent over extending the abutment member 124 andexerting a pinching force on the datum 108 that may damage the datumprojection 122 a and/or the datum 108.

In one embodiment, the lower handle 130 extends from the datumsecurement 122. The lower handle may be generally aligned with thehandle axis 120 a. The lower handle 130 may include a grip 132. In oneembodiment, the grip 132 is integral with the lower handle 128 and mayinclude a plurality of indentations 132 a. Alternatively, the grip 132may be a separate component and/or have a textured surface.

The distractor 122 may include a tissue engaging portion 134. In oneembodiment, the upper handle 136 extends from the tissue engagingportion 134. The upper handle 136 may include a distal portion 136 eattached to the tissue engaging portion 134 and a grip portion 136 fattached to the distal portion 136 e. The grip portion 136 f of theupper handle 136 may include a plurality of grips 136 a. In oneembodiment, the grips 136 a include a plurality indentations 136 aseparated by columns that are oriented perpendicular to a longitudinalaxis 120 a of the handle 130. The grips 136 a may have any suitableshape such as scalloped or cylindrical.

The distal portion 136 e and the grip portion 136 f may be joined at aninflection or pivot point 136 d. In one embodiment, the grip portion 136f of the upper handle 136 extends from the inflection point 136 f at anangle relative to the lower handle 130 as shown in FIG. 10A. The distalportion 136 e may be generally parallel with the axis 120 a in aninsertion position. The upper handle 136 may extend from the inflectionpoint between a range of angles that allows a user to grip the upper andlower handles 136, 130 with one hand while allowing sufficient movementof the tissue engaging portion 134 relative to the datum 108. In oneembodiment, the upper handle 136 may extend from the inflection point atapproximately 30 degrees as shown in FIG. 10A. The upper handle 136 maybe convexly shaped away from the lower handle 130 so as to make theupper handle 136 closer to being parallel with the lower handle 130 tomake gripping of the distractor 120 easier. In one embodiment, the upperhandle 136 is pivotable with respect to the lower handle 130 such thatsqueezing the upper and lower handles 130, 136 together spaces thetissue engaging portion 134 from the datum securement 122. In oneembodiment, the lower handle 130 is releasably attached to the upperhandle 136. The lower handle 130 may include a socket 130 a thatrotatably supports an axle (not visible) on the upper handle 136. In oneembodiment, the socket 130 a is partially open, e.g. C-shaped, such thatthe upper handle 136 is removable proximally from the lower handle 130.The axle of the upper handle 136 may be spring biased within the socket130 a by a first biasing member 138. The first biasing member 138 may bea cantilever spring. In an alternative embodiment, the lower and upperhandles 130, 136 have a scissor orientation such that the lower handle130 extends from the tissue engaging portion 134 and the upper handle136 extends from the datum securement 122.

In one embodiment, the tissue engaging portion 134 includes a paddle 140configured to engage the first resected tissue surface 100. The paddle140 may be pivotably attached to the upper handle 136 such that thepaddle 140 remains at a generally constant angle during separation ofthe first and second bones 12, 14 to maintain contact with the firstresected tissue surface 100 during distraction of the first and secondbones 12, 14. In one embodiment, the paddle 140 may remain generallyparallel to the second resected tissue surface 100 as the tissueengaging portion 134 is pivoted from the datum securement 122. Thepaddle 140 and upper handle 136 may be pivotable about axes that aregenerally parallel to one another.

In one embodiment, a portion of the paddle 140 may be at least partiallynarrower than the space between the pin apertures 112 of the datum 108such that the paddle 140 can be slid out between the shoulder pins 114after securing the datum 108 to the second resected tissue surface 104.In one embodiment, the paddle 140 includes an enlarged end 140 a. In oneembodiment, the enlarged end 140 a is wider than the space between thepin apertures 112 of the datum 108 to provide, for example, increasedsurface area for contacting the first resected tissue surface 100 andkeeping surrounding tissue clear from the second resected tissue surface104. The paddle 140 may also be enlarged toward the enlarged end 140 ato provide more weight proximal to the axis of rotation such that paddle140 tends to lay parallel with the extending upper handle 136 whenreleased. The paddle 140 may be partially recessed within the extendingupper handle 136 such that the paddle 140 is nearly flush and/orparallel with the upper handle 136 in the insertion position. In oneembodiment, the paddle 140 may include one or more ribs 140 c (FIG. 10C)that extends downwardly from the paddle 140 into a recess 136 b of theupper handle in the insertion position. In one embodiment, the ribs 140c may be provided to generally stiffen and minimize bending of theenlarged end 140 a while allowing the paddle 140 to be generally flushor parallel with the upper handle 136.

The proximal ends 136 c, 130 b of the upper and lower handles 136, 130may be connected by a ratchet 142 such that distractor 120 can be heldin a distracted position (FIG. 25) without a user having to continuallysqueeze the handles 130, 136. The ratchet 142 may include a plurality ofteeth 142 a that engage a projection (not shown) of the upper handle 136and prevent the upper handle 136 from returning to the insertionposition. The ratchet 140 may be spring biased via a second biasingmember 144. In one embodiment, the second biasing member 144 is acantilever spring secured to the lower handle 130.

In one embodiment, the upper handle 136 may be removed from the lowerhandle 130 if distraction of the first and second resected tissuesurfaces 100, 104 is not necessary (e.g. for a lax joint) and/or todisengage and the ratchet 142 such that the upper handle 136 is freelypivotable relative to the lower handle 130. The ratchet 142 may bedisengaged from the upper handle 136 by pulling back on the ratchet,removing the upper handle 136 from the lower handle 130 and pivoting theratchet 142 downwardly so that it lies on the lower handle 130 (FIG.10D). Once the ratchet 142 has been disengaged from the upper handle136, the upper handle 136 re-attached to the lower handle 130 such thatthe distractor 120 functions without the ratchet 142. The ratchet 142optionally includes a grip 142 b that extends upwardly past or throughthe upper handle 136 such that the ratchet 142 may be gripped and pulledrearwardly or proximally to disengage the ratchet 140 from the upperhandle 136. In one embodiment, the grip 142 b is an indent. The grip 142b of the ratchet 142 may receive a portion of the datum lock 126 in thefolded position (FIG. 10D) such that the ratchet 142 b may lie flatagainst the lower handle 130. Alternatively, the ratchet 142 may have ashorter length than shown such that the datum lock 126 may be used whilethe ratchet 142 lies against the lower handle portion 130.

Third Tissue Resection Guide

Referring to the embodiment of FIGS. 11A-11B, a third tissue resectionguide 146 may be provided for resecting, for example, the second bone14. The third tissue resection guide 146 may be sized and configured toreleasably attach to the top side 108 f of the datum 108 and guide oneor more tissue resection tools. In one embodiment, the third tissueresection guide 146 is an anterior/posterior tissue resection guide forresecting the second bone 14 anterior and posterior to the datum 108.The third tissue resection guide 146 may be used to resect the secondbone 14 in any direction relative to the datum 108. The third tissueresection guide 146 includes a base 148 that releasably engages thedatum 108. The base 148 may include a datum projection 148 a thatextends from the base 148 and fits within the recessed section 108 d ofthe datum 108 to prevent the third tissue resection guide 146 fromrotating with respect to the datum 108. The datum projection 148 a mayinclude an aperture 148 b for receiving a fastener 150 configured tosecure the third tissue resection guide 146 to the datum 108. In oneembodiment, the fastener 150 is an Allen screw. However, the fastener150 may be any securement device such as a snap. The base 148 mayinclude pin apertures 148 c for fitting over the shoulder pins 114extending from the datum 108. The pin apertures 148 c may be angled awayfrom the base 148 such that the pins 42 remain out of the way andprovide a more stable support from the second bone 14.

The third tissue resection guide 146 may include a first frame 152attached to the base 148. In one embodiment, the first frame 152 isintegral with the base 148. In one embodiment, the first frame 152 isadjacent to the fourth side 108 e of the datum 108 when the third tissueresection guide 146 is engaged with the datum 108 (e.g., FIG. 28).

The first frame 152 may include or define one or more guide paths (e.g.,first and second guide paths 154, 156). In one embodiment, guide paths154, 156 are apertures within a frame (e.g., the first frame 152). Inone embodiment, the guide paths 154, 156 are elongate apertures. Forexample, in one embodiment, the guide paths 154, 156 are defined by aninner wall 152 a of a frame (e.g., the first frame 152). In theembodiment of FIG. 11A, for example, the guide paths 154, 156 aredefined by a continuous inner wall 152 a. In one embodiment, guide pathssuch as guide path 166 is defined a discontinuous inner wall 160 a. Alsoas illustrated in FIG. 11A, guide paths, such as guide paths 154, 156may extend through a frame (e.g., first frame 152) such that there is norestriction to a correctly sized tool passing though such a guide pathfrom one side of a frame to another. As will be illustrated in moredetail below, a guide path (such as guide path 180 c of FIG. 12B mayinclude a closed upper surface 180 a to restrict the movement of aresection tool when the resection tool is being guided in the guide path180 c.

In one embodiment, the first and second guide paths 154, 156 eachinclude an enlarged end 154 a, 156 a. The enlarged ends 154 a, 156 a(e.g., of adjacent guide paths) are optionally on opposite lateral sidesof the first frame 152. In one embodiment, the enlarged end 154 a offirst guide path 154 is proximate the lateral side of the ankle 24 andthe enlarged end 156 of the second guide path 156 is proximate themedial side of the ankle 24 during use as shown in the embodiment ofFIGS. 28 and 29 such that a resection tool (e.g. a milling bit) 168spinning clockwise tends to pull away from the base 148 caused by thecontact between the resection tool and the second bone 14. In oneembodiment, the orientation of the enlarged ends 145 a, 156 a may bereversed (not shown) for a resection tool 168 spinning in acounterclockwise direction. The first and second guide paths 154, 156may be generally parallel to each other. The first and second guidepaths 154, 156 may be generally parallel to the fourth side 114 e of thedatum. In one embodiment, the centers 154 b, 156 b of the first andsecond guide paths 154, 156 are spaced a distance D.sub.1 that is lessthan a diameter D.sub.2 of the enlarged end 154 a of the first guidepath 154. In one embodiment, the spacing of the guide paths 154, 156allows for an overlapping resection path as discussed further below. Thecenter 154 b of the first guide path 154 may be spaced from the fourthside 108 e of the datum 108 a distance approximately equal to half ofthe diameter D.sub.2 of the enlarged end 154 a of the first guide path154 such that the resection path nearly abuts the fourth side 108 e ofthe datum 108. The first frame 152 may include one or more pin supports158 each configured to receive a pin 42 (see FIG. 27) for furtherstabilizing the third tissue resection guide 146 relative to the secondbone 14.

In one embodiment, each of the first and second guide paths 154, 156 areconfigured to receive and guide a tissue resection tool such as a secondtissue resection tool 168. (See FIG. 27). The second tissue resectiontool 168 may be a milling bit though the second tissue resection tool168 may be any tissue resection tool such as a blade. The second tissueresection tool 168 may include an enlarged cutting head 168 a. In oneembodiment, the cutting head 168 a fits through the enlarged ends 154 a,156 a of the first and second guide paths 154, 156 respectively but doesnot fit through the remainder of the first and second guide paths 154,156. The remainder of the first and second guide paths 154, 156 may benarrowed from the enlarged ends 154 a, 156 a to more closely fit anotherfeature of a resection tool such as the diameter of a shaft 168 b of thesecond tissue resection tool 168.

In one embodiment, the second tissue resection tool 168 includes a stop168 c that abuts a top surface of the first frame 152 to limit thedistance the second tissue resection tool 168 extends through the firstframe 152 as shown in FIG. 28. In one embodiment, the stop 168 c isrotatable with respect to the shaft 168 b thereby significantly reducingthe amount that the stop 168 c rotates against and wears the top surfaceof the first frame 152.

The third tissue resection guide 146 is sized and configured to guidethe second tissue resection tool 168 proximate the fourth side 108 e ofthe datum 108. In one embodiment, third tissue resection guide 146 issized and configured to guide the second tissue resection tool 168 toresect the second bone 14 and to further expose the second resectedtissue surface 104 in a direction away from the fourth side 108 e of thedatum 108. In one embodiment, the further exposed second resected tissuesurface 104 is a second resected tissue surface expansion 104 b (bestillustrated in FIGS. 30 and 33). In one embodiment, the second resectedtissue surface 104 is expanded in the anterior direction. The fourthresected tissue surface 104 b may be generally normal to the fourth side108 e of the datum 108. In one embodiment, each guide path 154, 156 isused to expose the fourth resected tissue surface 104 b. (See FIGS. 28and 29). The first and second guide paths 154, 156 may be configured toallow for overlapping resections by the second tissue resection tool 168such that the first and second guide paths 154, 156 create a planarfourth resected tissue surface 104 b (See FIGS. 28 and 30).Alternatively, the first frame 152 includes a single guide path 154 ormore than two guide paths 154, 156.

With continued reference to the embodiment shown in FIGS. 11A and 11B,the third tissue resection guide 146 optionally includes a second frame160 adjacent to the first side 108 a of the datum 108. The third tissueresection guide 146 may be sized and configured to receive and guide athird tissue resection tool 170. The third tissue resection tool 170 mayfurther expose or expand the second resected tissue surface 104 in adirection away from the datum 108. (See FIG. 26). In one embodiment, thefurther exposed second resected tissue surface 104 is a third resectedtissue surface 104 a (best illustrated in FIGS. 30 and 33). Referring tothe embodiment of FIG. 27, the third tissue resection tool 170 may be ablade with a cutting end 170 a. The third tissue resection tool 170 isconfigured to slide back and forth within the guide path 166 such thatthe cutting end 170 a resects tissue and expands the second resectedtissue surface 104 to further expose the third resected tissue surface104 a.

The second frame 160 may include a guide path 166. In one embodiment,the guide path 166 includes a partially open sidewall 160 c defined bysidewall segments 162, 164. In one embodiment, each sidewall 162, 164extends from the base 148 and wraps around toward each other to definethe guide path 166. Sidewall 162, 164 may taper to a center point 162 a,164 a. In one embodiment, a benefit of an at least partially opensidewall 160 c includes permitting a user to view a tissue resectiontool within the guide path 166. In one embodiment, the partially opensidewall 160 c permits viewing of the third tissue resection tool 170and/or the third resected tissue surface 104 a (FIG. 27) while the thirdtissue resection tool 170 is resecting tissue.

In one embodiment, a guide path 166 is defined by inner walls 162 b, 164b. In one embodiment, a first side 108 a of the datum 108 and a feature(e.g. an edge 148 f) of the base 148 are aligned with at least one innerwall of the frame 160 when the third tissue resection guide 146 isengaged with the datum 108.

In one embodiment, the guide path 166 may be generally aligned in aplane with the first side 108 a of the datum 108 when the third tissueresection guide 146 is engaged with the datum. For example, in FIGS. 27and 29, the third tissue resection guide 146 and datum 108 may define atemplate or resection plane that is aligned with the third resectedtissue surface 104 a and in which the third tissue resection tool 170 ismoved along. In one embodiment, the resection plane corresponds to adesired cut surface of a bone to match a feature of the total jointreplacement 10. In one embodiment, the resection plane may be defined bya feature (e.g., inner wall 162 b) of the second frame 160 or by acombination of one or more features of the second frame 160 and afeature of the base 148. In one embodiment, sidewalls 162, 164 define aslot with inner edge 148 f that is slightly larger than a preselectedthickness of the third resection tool 170 and wider than a preselectedthickness of the third resection tool 170 to allow the third resectiontool 170 to slide from side to side within the guide path 166 but smallenough to constrain undesirable movement away from the base 178.

In one embodiment, there are no sidewalls 162, 164 on the second frame160 such that the guide path 166 is entirely open toward one side. Insuch an embodiment, care should be taken not to contact the medial andlateral malleolus 12 e, 16 a rather than rely on the sidewalls 162, 164to stop the second tissue resection tool 170. In one embodiment, thesecond frame 160 of the third tissue resection guide 146 has an entirelyclosed perimeter wall (not shown). In one embodiment, the thirdresection guide 146 does not include a second frame 160 and the thirdresected tissue surface 104 a is exposed by sliding the third tissueresection tool 170 against the first side 108 a of the datum 108. Thethird tissue resection guide 146 may include indicia 172 such as acolored polymeric plug that indicates the size and/or right or left foot26.

Fourth Tissue Resection Guide

Referring to the embodiment of FIGS. 12A-12C, a fourth tissue resectionguide 176 may be provided for resecting the second bone 14. The fourthtissue resection guide 176 is sized and configured to releasably attachto the top side 108 f of the datum 108 (see FIGS. 31 and 32). The fourthtissue resection guide 176 is also configured to receive and guide oneor more resection tools to resect tissue at predetermined orientationand location. In one embodiment, a resection using the fourth tissueresection guide 176 is made while fourth tissue resection guide 176 isattached to the datum 108 and while the datum 108 is attached to tissue(e.g., the second resected tissue surface 104). In one embodiment, thefourth tissue resection guide 176 is configured to guide one or moretissue resection tools adjacent to the datum 108. In one embodiment, thefourth resection tool 182 is guided adjacent to one or more sides of thedatum 108. In one embodiment, the fourth resection tool 182 is guidedadjacent to different sides of the datum 108 than the sides of the datum108 that are adjacent to the resections made when the third tissueresection guide 146 is used as described above. In one embodiment, thefourth tissue resection guide 176 is a medial/lateral tissue resectionguide for resecting the second bone 14 medial and lateral to the datum108. However, the fourth tissue resection guide 176 may be used toresect the second bone 14 in any direction relative to the datum 108.

The fourth tissue resection guide 176 includes a base 178 thatreleasably engages the datum 108. The base 178 may include a datumprojection 178 a that extends from the base 178 and fits within therecessed section 108 d of the datum 108 to prevent the fourth tissueresection guide 176 from rotating with respect to the datum 108. Thedatum projection 178 a may include an aperture 178 b for receiving afastener 150 configured to secure the fourth tissue resection guide 176to the datum 108. In one embodiment, the fastener 150 is an Allen screw.However, the fastener 150 may by any securement device such as a snap ormagnet. The fastener 150 may be the same fastener 150 used to secure thethird tissue resection guide 146 to the datum 108. In one embodiment,each of the third and fourth tissue resection guides 146, 176 mayinclude its own fastener 150. The base 178 may include pin apertures 178c for fitting over the shoulder pins 114 extending from the datum 108.In one embodiment, the fourth tissue resection guide 176 is integralwith the third tissue resection guide 146. The base 178 may include oneor more grips 178 d (see FIG. 12A) that are configured to engage aninsertion tool (not shown) such as forceps. In one embodiment, the grips178 d may be apertures as shown.

The fourth tissue resection guide 176 may include a first frame 180attached to the base 178 (e.g., such that the first frame 180 isintegral with the base 178 or a separate component that is combined withthe base 178). In one embodiment, the first frame 180 is adjacent to thesecond side 108 b of the datum 108 when the fourth tissue resectionguide 176 is engaged with the datum 108 and is configured to receive andguide a tissue resection tool such as the fourth tissue resection tool182. (See FIG. 31).

The first frame 180 may include a guide path 180 c for capturing andguiding the fourth tissue resection tool 182. In one embodiment, theguide path 180 c is a generally planar elongated slot. In oneembodiment, the guide path 180 c is defined at least in part by an innersurface 180 g of the first frame 180 and an outer surface 178 g of thebase 178. When the fourth tissue resection guide 176 is engaged with thedatum 108 the guide path 180 c may be further defined, at least in part,by the second side 108 b of the datum 108.

In one embodiment, the guide path 180 c of the first frame 180 is atleast partially closed proximate a top 178 f of the base 178 via aclosed top 180 a. In one embodiment, the guide path 180 c issubstantially open proximate the bottom 178 e of the base 178. In oneembodiment, the closed top 180 a and open bottom of the guide path 180 cpermit the resection tool to move freely in a direction toward thesecond bone 12 but restricts the resection tool in a direction normal tothe base 178 such that the resection tool may be slid downwardly out ofthe fourth resection guide 176 but not upwardly out of the fourthresection guide 176. The closed top 180 a may be provided so that thefourth tissue resection tool 182 can be pivoted up against the closedtop 180 a during use. The closed top 180 a may include a rounded inneredge 180 b to contact the fourth tissue resection tool 182 and prevent apointed contact between the first frame 180 and the fourth tissueresection tool 182. The first frame 180 may be open toward the bottom178 e of the base 178 such that the fourth tissue resection tool 182 mayextend downwardly past the base 178 and resect the second bone 14 tofurther expose a fifth resected tissue surface 104 c. The guide path 180c may be generally parallel to the second side 108 b of the datum 108when the fourth tissue resection guide 176 is engaged with the datum108. Alternatively, the guide path 180 c may be defined solely by thefirst frame 180 or solely between the first frame 180 and the base 178.In one embodiment, the guide path 180 c of the first frame 180 is agenerally rectangular slot.

In one embodiment, the fourth tissue resection tool 182 is a saw blade.However, the fourth tissue resection tool 182 may be any suitableresection device such as any one of the first, second and third tissueresection tools 168, 170 described above (the first tissue resectiontool is not shown).

The first frame 180 of the fourth tissue resection guide 176 may includeat least one viewing window 186 extending through an outer side 180 d ofthe first frame 180. In one embodiment, the first cut guide 180 includestwo viewing windows 186 a, 186 b. The outer side 180 d of the firstframe 180 may include an alignment feature such as an alignment line 188(best shown in FIG. 31) that extends across or intersects the at leastone viewing window 186 such that during use the depth of the fourthtissue resection tool 182 can be determined by aligning a feature 182 aof the fourth tissue resection tool 182 such as the top edge of thefourth tissue resection tool 182 with the alignment line 188. (See FIG.31). In one embodiment, the alignment line 188 is cut or etched into theouter side 180 d of the first frame 180. Alternatively, the alignmentline 188 may be printed or otherwise affixed to the outer side 180 d ofthe first cut guide 180. The first frame 180 may be used to resect orexpose the fifth resected tissue surface 104 c. (See FIGS. 31 and 32).

Referring to FIGS. 31 and 32, in one embodiment, the fifth resectedtissue surface 104 c extends medially from the second resected tissuesurface 104. In one embodiment, the fifth resected tissue surface 104 cis generally parallel with the second side 108 b of the datum 108. Inone embodiment, approximately 0.5 mm to approximately 6 mm of tissue maybe removed from second bone 14 to expose the fifth resected tissuesurface 104 c. In one embodiment, approximately 2 mm to approximately 3mm of tissue is removed from second bone 14 proximal the second side 108b of the datum 108. The inferior extending length of the fifth resectedtissue surface 104 c may be approximately 5 mm to approximately 15 mm.In one embodiment, the inferior extending length of the medial extension106 c is approximately 10 mm.

The fourth tissue resection guide 176 may include a second frame 190attached to the base 178. In one embodiment, the second frame 190 is ageneral mirror image of the first frame 180. In one embodiment, thesecond frame 190 and the first frame 180 are attached to the base 178 ina general symmetrical configuration (see, e.g., FIGS. 12A and 12B). Inone embodiment, the second frame 190 and the first frame 180 areoriented to provide guides that facilitate serial medial and lateralresections while the fourth tissue resection guide 176 is attached tothe datum 108 and the datum 108 is attached to the second bone 14 (e.g.,without the need to detach and attach a cut guide to the second bone 14between medial and lateral resections).

In one embodiment, the second frame 190 is adjacent to the third side108 c of the datum 108 when the fourth tissue resection guide 176 isengaged with the datum 108 and is configured to receive and guide atissue resection tool such as the fourth tissue resection tool 182(similar to the first frame 180 shown in FIG. 31). In one embodiment,the second frame 190 is integral with the base 178 or a separatecomponent that is combined with the base 178. The second frame 190 mayinclude a guide path 190 c for capturing and/or guiding the fourthtissue resection tool 182. In one embodiment, the guide path 190 c isdefined at least in part by an inner surface 190 g of the first frame190 and an outer surface 178 h of the base 178. When the fourth tissueresection guide 176 is engaged with the datum 108. The guide path 180 cmay be further defined, at least in part, by a third side 108 c of thedatum 108.

In one embodiment, the guide path 190 c of the second frame 190 is atleast partially covered or closed proximate a top 178 f of the base 178via a closed top 190 a. In one embodiment, the guide path 190 c issubstantially open proximate the bottom 178 e of the base 178. In oneembodiment, the closed top 190 a and open bottom permit the resectiontool to move freely in a direction toward the second bone 12 butrestricts the resection tool in a direction normal to the base 178 suchthat the resection tool may be slid downwardly out of the fourthresection guide 176 but not upwardly. The closed top 190 a may beprovided so that the fourth tissue resection tool 182 can be pivoted upagainst the closed top 190 a during use. The closed top 190 a of thesecond frame 190 may include a rounded inner edge 190 b to contact thefourth tissue resection tool 182 and prevent a pointed contact betweenthe first frame 190 and the fourth tissue resection tool 182. The secondframe 190 may be open toward the bottom 178 e of the base 178 such thatthe fourth tissue resection tool 182 may extend downwardly past the base178 and resect the second bone 14 to further expose a sixth resectedtissue surface 104 d. The guide path 190 c may be generally parallel tothe third side 108 c of the datum 108 when the fourth tissue resectionguide 176 is engaged with the datum 108. Alternatively, the guide path190 c may be defined solely by the second frame 190 or solely betweenthe second frame 190 and the base 178. In one embodiment, the guide path190 c of the second frame 190 is a generally rectangular slot.

The second frame 190 of the fourth tissue resection guide 176 mayinclude at least one viewing window 192 extending through an outer side190 d of the second frame 190. In one embodiment, the second frame 190includes two viewing windows 192 a, 192 b. The outer side 190 d of thesecond frame 190 may include an alignment line 194 (best shown in FIG.12A) that extends across the at least one viewing window 192 such thatduring use the depth of the fourth tissue resection tool 182 can bedetermined by aligning a feature 182 a of the fourth tissue resectiontool 182 such as the top edge of the fourth tissue resection tool 182with the alignment line 194. In one embodiment, the alignment line 194is cut or etched into the outer side 180 d of the second frame 190.Alternatively, the alignment line 194 may be printed or otherwiseaffixed to the outer side 190 d of the second frame 190. The secondframe 190 may be used to resect or expose a sixth resected tissuesurface 104 d. (See FIG. 32).

Referring to FIG. 32, in one embodiment, the sixth resected tissuesurface 104 d extends laterally from the second resected tissue surface104. In one embodiment, the sixth resected tissue surface 104 d isgenerally parallel with the second side 108 b of the datum 108.Approximately 0.5 mm to approximately 6 mm of tissue may be removed fromsecond bone 14 to expose the sixth resected tissue surface 104 d. In oneembodiment, approximately 2 mm to approximately 3 mm of tissue isremoved from second bone 14 proximal the third side 108 c of the datum108. The inferior extending length of the sixth resected tissue surface104 d is approximately 10 mm to approximately 25 mm. In one embodiment,the inferior extending length of the sixth resected tissue surface 104 dis approximately 17 mm.

In one embodiment, (e.g., as illustrated in FIG. 12A) the second frame190 is angled about an axis that is generally perpendicular to the top178 f of the base 178 such that the front edge 190 e is angled inwardlytoward the base 178. In one embodiment, the first frame 180 is angledabout an axis that is generally perpendicular to the top 178 f of thebase 178 such that the front edge 180 e is angled inwardly toward thebase 178 (not illustrated). In one embodiment (e.g., as illustrated inFIG. 12B), the first frame 180 and/or second frame 190 are angled towardeach other such that the closed tops 180 a, 190 a extend inwardly. Inone embodiment, the angle of inclination of the first frame 180 and thesecond frame 190 are different. In one embodiment, the angles ofinclination of the first and second frames 180, 190 are approximatelyequal to the angles of inclination of the respective second and thirdsides 108 b, 108 c of the datum 108.

In one embodiment, the ends 180 e, 190 e extend outwardly from the body178 and generally taper to a point to protect surrounding tissue fromthe fourth tissue resection tool 182. However, the ends 180 e, 190 e ofthe first and second frames 180, 190 may have any shape and may or maynot extend outwardly further from the body 178. In one embodiment, thetop 180 a of the first cut guide 180 extends further from the base 178than the top 190 a of the second cut guide 190 to allow for a deeperresection proximate the third side 108 c of the datum 108 than theresection proximate the second side 108 b of the datum 108. However, thefirst and second cut guides 180, 190 may be configured to make a similardepth cut or be oriented to make any desired resections proximate andrelative to the datum 108. In one embodiment, the fourth tissueresection tool 182 includes vertically extending teeth 182 c such thatthe teeth 182 c do not contact the first or second cut guides 180, 190during use.

Window Trial

Referring to the embodiment of FIG. 13, there is shown a window trial198. The window trial 198 may include one or openings 200 to evaluatethe resected second bone 14. The window trial 198 may be used toevaluate the second, third, fourth, fifth and sixth resected tissuesurface tissues 104, 104 a, 104 b, 104 c, 104 d. (See FIGS. 33 and 34).The window trial 198 may have an inner surface 198 a that generally hasthe shape of an inner surface of the second endoprosthetic component 18of the total joint replacement 10. The window trial 198 may have anouter surface 198 b that generally has the shape of an outer surface ofthe first endoprosthetic component 18 of the total joint replacement 10.In one embodiment, the window trial 198 has the same shape andconfiguration as the first endoprosthetic component 18 of the totaljoint replacement 10.

In one embodiment, the window trial 198 includes the one or moreopenings 200 for viewing and evaluating the shape of one or more of thesecond, third, fourth, fifth and sixth resected tissue surfaces 104, 104a, 104 b, 104 c, 104 d, 104 e. The window trial 198 may include sideopenings 200 a, 200 b proximate the fifth and sixth resected tissuesurface 104 c, 104 d respectively. In one embodiment, the side openings200 a, 200 b are generally aligned or parallel with the fifth and sixthresected tissue surface 104 c, 104 d respectively such that the fifthand sixth resected tissue surfaces 104 c, 104 d are not visible if theresections are proper when viewing the fifth and sixth resected tissuesurfaces 104 c, 104 d at a viewing angle that is parallel and in-linewith the fifth and sixth resected tissue surfaces 104 c, 104 drespectively. In one embodiment, first and second top openings 200 c,200 d expose the second and fourth resected tissue surfaces 104, 104 brespectively. The first and second top openings 200 c, 200 d may eachexpose the second resected tissue surface 104 proximate the thirdresected tissue surface 104 a such that the inner surface 198 a of thewindow trial 198 proximate the third resected tissue surface 104 a isvisible.

The window trial 198 may include a fin aperture 200 e. In oneembodiment, a keel mill or wire driver (not shown) is used to cut a keelslot (not shown) into the second 14 using the fin aperture 200 e as aguide. The keel slot may be made for receiving the fin 18 b of the firstendoprosthetic component 18. The window trial 198 may include one ormore pin apertures 204 for securing the window trial 198 to the secondbone 14 using one or more pins 42. The window trial 198 optionallyincludes a handle 202 to assist in installing and removing the windowtrial 198 from the second bone 14 using a tool such as forceps (notshown). The window trial 198 may include indicia (not shown) such as acolored polymeric plug or printed graphic that indicates the size and/orright or left foot 26.

Barrel Cut Guide

Referring to the embodiment of FIG. 17, a barrel cut guide 208 may beprovided. The barrel cut guide 208 may be configured to guide a fifthtissue resection tool 210 used to form the resected cavities 12 a thatreceive the projections 20 a of the second endoprosthetic component 20.(See FIGS. 1 and 2). In one embodiment, the fifth tissue resection tool210 is a drill bit. In one embodiment, the barrel cut guide 208 includesa support plate 212. The support plate 212 may contact the firstresected tissue surface 100 during use. The support plate 212 may alsobe used to measure the first resected tissue surface 100 for theappropriately sized second endoprosthetic component 20. In oneembodiment, various support plates 212 are provided that correspond tothe size of the second endoprosthetic component 20. In an alternativeembodiment, the support plate 212 is partially transparent and includesvarious size markings for determining the size of the secondendoprosthetic component 20.

The barrel cut guide 208 may be fixed to the first bone 12 by one ormore pins 42. The barrel cut guide 208 may include a height adjuster 214that may be used to space the barrel cut guide 208 an appropriatedistance from the first bone 12. The space between the barrel cut guide208 may be adjusted using the height adjuster 214 after the pins 42 areset if the pins 42 are inserted generally parallel with the heightadjuster 214 or the length of height adjuster 214 extending from thebarrel cut guide 208 may be set prior to inserting the pins 42 if thepins are inserted at an angle as shown. In one embodiment, the heightadjuster 214 is a manually adjustable screw. However, the heightadjuster 214 may be any device suitable to space the barrel cut guide208 from the first bone 12.

The barrel cut guide 208 may include a body 216 that extends generallyperpendicular from the support plate 212 such that the body 216 extendsat least partially over the top of the first bone 12. The body 216 mayinclude two apertures 216 a (only one shown in FIG. 35) that aregenerally sized and shaped similar to the projections 20 a of the secondendoprosthetic component 20 and guide the fifth tissue resection tool210. The fifth tissue resection tool 210 may include a shoulder 210 athat contacts the body 216 and a maximum drilling depth to limit thedepth of the resected cavities 12 a a predetermined distance.

Referring to the embodiment of FIG. 15, the resected cavities 12 a maybe opened or exposed through the first resected tissue surface 100 usinga fin cutter 218 that is inserted through the apertures 216 a, 216 b ofthe barrel cut guide 208. In one embodiment, the fin cutter 218 includesa pair of fins 220 that are generally parallel and spaced apart from oneanother. The fins 220 may be configured to cut perpendicularly throughthe first resected tissue surface 100 through the resected cavities 12a. The support plate 212 may include slots 212 a, 212 b for receivingthe fins 220 and the bone that is cut out by the fins 220. The fincutter 218 may include a shaft 218 a that is generally equal in size tothe resected cavities 12 a and a limit stop 218 b that contacts the body216 once the fins 220 have reached the end of the resected cavities 12a.

Method of Use

Referring to FIGS. 16-35, there are shown exemplary embodiments of usingthe various instrumentation disclosed above for implanting the totaljoint replacement 10. Referring to FIG. 16, after the foot 26 and ankle24 have been correctly positioned, the foot 26 and ankle 24 arepreferably elevated. The foot 26 and ankle 24 are elevated forapproximately two minutes. A high thigh tourniquet (not shown) may beinflated or tightened with an appropriate amount of pressure for thesize of the leg 84 and foot 26. An incision 224 may be made along theanterior side of the ankle 24 parallel to the leg 84 to expose the jointbetween the tibia 12 and the talus 14. The incision 224 may beapproximately 5 cm to approximately 30 cm in length. In one embodiment,the incision 224 is approximately 20 cm in length. The incision 224 maybe centered over the ankle 24 immediately lateral to an anterior tibialtendon (not shown). The incision 224 may be deepened into the ankle 224while moving the extensor hallucis longus (not shown) and theneurovascular bundle laterally. The incision 224 may expose thesuperficial dorsal peroneal nerve (not shown) and should be retractedcarefully to the lateral side. In one embodiment, it may be necessary tosacrifice one branch of the superficial dorsal peroneal nerve that goesto the first metatarsal. The incision 224 may open the tendon sheath ofthe extensor hallucis longus (not shown) inline with the incision 224.In one embodiment, every effort is made not to open the anterior tibialtendon sheath (not shown) as such action might cause bolstering of thetendon during closing of the incision 224.

After the extensor hallucis longus tendon sheath is opened, the deepperoneal nerve and artery (not shown) which are just beneath the tendonsheath, may be retracted laterally in a gentle manner. The capsulartissues (not shown) in the ankle 24 may be incised in line with theincision 224 and then elevated and mobilized to expose the medialmalleolus 12 b (see FIG. 1) and the entire ankle joint. Care should betaken not to release the anterior talofibular ligament (not shown) asthis will produce ankle instability.

The ankle joint may be distracted slightly using any suitable tool andexcess synovium (not shown) and any loose bodies or bone spurs areremoved using any suitable technique. In one embodiment, the anteriorosteophytes (not shown) are excised so the tibial plafond 12 c can bevisualized. Retractors 226 are optionally used to hold the incision 224open. In one embodiment, manually positioned retractors 226 are usedover self retaining retractors. The retractors 226 may be frequentlyrepositioned to minimize the risk of tissue trauma.

Referring to FIG. 17, the alignment guide 30 may be secured to the firstbone 12 by inserting the pin 34 into a first end 12 d of the first bone12. In one embodiment, the first end 12 d is the anterior tibialtubercle of the tibia. The pin 34 may be oriented approximatelyperpendicular to first bone 12. In one embodiment, the alignment guide30 is positioned relative to the pin 34, both anteriorly and laterally,and secured to the pin 34 using the first securement 36.

In one embodiment, the attachment block 38 is positioned proximate asecond end 12 c of the first bone 12. In one embodiment, the second end12 c is the tibial plafond of the tibia. The positioning tool 46 may besecured to the second positioning block 54 to assist in positioning theattachment block 38 relative to the first bone 12. The attachment block38 may be secured to the first bone 12 using one or more pins 42. Thesecond securement 40 may be tightened to fix the length between theattachment block 38 and the first end 30 a of the alignment guide 30.

In one embodiment, an osteotome (not shown), placed within the medialgutter, is used for additional visualization and setting properorientation of the attachment block 38. The space adjustments 48 may beused to stabilize the attachment block 38 with respect to the first bone12. In one embodiment, the distance between the attachment block 38 andthe first bone 12 is as small as possible. In one embodiment, theattachment block 38 is positioned the approximate distance from thefeature 12 c of the first bone 12 such as the tibial plafond. A C-arm orother imaging device may be used to align the alignment rod 44 generallyparallel with the longitudinal axis of the first bone 12. In oneembodiment, the alignment rod 44 is generally aligned with a bonefeature 12 f in the anterior/posterior and lateral views (lateral viewshown). In one embodiment, the bone feature 12 f is the tibial crest ofthe tibia.

Referring to FIG. 18, once the attachment block 38 has be secured to thefirst bone 12, the first tissue resection guide 66 is attached to thesecond positioning block 58.

Referring to FIGS. 19 and 20, the spacer guide 78 may be attached to thefirst tissue resection guide 66 by inserting the mount 82 into the firstguide path 70 of the first tissue resection guide 66. The C-arm or otherimaging device may be used to view the ankle 24 from the lateral sideproximate the extension arm 80 of the spacer guide 78. In oneembodiment, the projections 86 are used to set the position firstpositioning block 50. In one embodiment, a single spacer guide 78 may beused for viewing the ankle 24 from either the medial or lateral side(FIG. 20). The spacer guide 78 may be removed and the C-arm or otherimaging device may be used from the anterior side of the ankle 24. Inone embodiment, the first tissue resection guide 66 is positioned byusing the second positioning block 58 and by aligning the first guidepath 70 between the between the medial and lateral malleolus 12 e, 16 a.

Once the position of the first tissue resection guide 66 is determined,pins 42 are inserted into the superior-most pin apertures 50 b, 50 b′ ofthe respective plurality of pin apertures 50 a, 50 a′ in the firstpositioning block 50. In one embodiment, pins 42 may be placed withinthe pin apertures 70 a, 70 b in the first tissue resection guide 66 toprotect the medial and lateral malleolus 12 e, 16 a. In one embodiment,the first tissue resection tool such as a blade (not shown) is insertedwithin the first guide path 70 to resect or cut the distal end of thefirst bone 12 along a first cut line 228 (FIG. 18). The blade may beplaced against the second guide path 72 to resect or cut a second cutline 230 (FIG. 18).

In one embodiment, when the alignment rod 44 is aligned with the feature12 f of the first bone 12, the top of the guide path 94 is angled backtoward the alignment guide 30 such that the guide path 94 is at anapproximately 87 degree angle with respect to the first bone 12. Thisallows for an angled first resected tissue surface 100 as best shown bythe angle of the spacer guide 78 in FIG. 20 and the angle of the secondendoprosthetic component 20 in FIG. 2. The angle of the guide path 94relative to the first bone 12 may be altered by raising or dropping thefirst end 30 a of the alignment guide 30 along the pin 34. The angle ofthe guide path 94 relative to the first bone 12 may be approximately 85degrees to approximately 95 degrees and may have any orientation whenthe alignment rod 44 is generally parallel to longitudinal axis of thefirst bone 12. Once the guide path 94 is set to the desired positioned,the first resection tool is used to resect the first bone 12 along thefirst and second cut lines 228, 230. The resections along the first andsecond cut lines 228, 230 expose the first resected tissue surface 100(FIG. 20).

Referring to FIG. 21, after the first resected tissue surface 100 isexposed, a second tissue resection guide 90 is inserted onto the firsttissue resection guide 66. The foot 26 may be moved to a generalplantigrade position (shown) such that the top of the second bone 14engages the first resected tissue surface 100 or the tab extension 102′.The spacer guide 78 may be used to verify neutral positioning of thesecond bone 14. In one embodiment, the second tissue resection guide 90is secured to the second bone 14 by pins 42 extending through the pinmounts 92. In such an embodiment, the second bone 14 is now fixedrelative to the alignment guide 30. The first tissue resection tool maybe inserted within the guide path 94 of the second tissue resectionguide 90 to resect or cut the second bone 14 exposing the secondresected tissue surface 104.

Referring to FIG. 22, once the first and second resected tissue surfaces100, 104 have been exposed, a space evaluator 234 may be insertedbetween the first and second resected tissue surfaces 100, 104 to ensurethat the proper amount of tissue from the first and second bones 12, 14has been resected. In one embodiment, the space evaluator 234 includes aplurality of finger grips 234 c. The finger grips 234 c may be inwardlyextending grooves positioned on at least one side or lateral edge of thespace evaluator 234.

The space evaluator 234 may have a predetermined thickness toward afirst end 234 a and a predetermined thickness toward a second end 234 b.In one embodiment, the thickness of the first end 234 a is approximately6 mm to approximately 20 mm. In one embodiment, the thickness of thefirst end 234 a is approximately 12 mm. For example, the first end 234 ahaving a 12 mm thickness may include 3 mm of space for the secondendoprosthetic component 20, 6 mm of space for the middle endoprostheticcomponent 22 and 3 mm of space for the first endoprosthetic component18. If the space evaluator 234 does not fit between the first and secondresected tissue surfaces 100, 104, the first bone 12 may be furtherresected. In one embodiment, the space evaluator 234 has a thinnerthickness (e.g. approximately 9 mm) toward a second end 234 b in theevent that the distance measured using the spacer guide 78 is off, themeasurement included cartilage or other non-bone tissue or if a joint islax. In one an embodiment, if the final distance between the first andsecond resected tissue surfaces 100, 104 is thinner than the thicknessof the first end 234 a of the space evaluator 234, the second end 234 bof the space evaluator 234 may be inserted between the first and secondresected tissue surfaces 100, 104 to gauge the additional space needed.For example, if the second end 234 b of the space evaluator 234 fitssnugly between the first and second resected tissue surfaces 100, 104then an additional distance, such as 2 mm, can be resected from thefirst bone 12. The first bone 12 may be further resected by removing thepins 42 from first positioning block 50, moving the first positioningblock 50 one or more predetermined length increments (e.g. 2 mm) suchthat the original pin holes 50 b, 50 b′ in the first bone 12 align withthe adjacent pin holes 50 c, 50 c′ and then reinserting the pins 42 intothe first positioning block 50 through the pin holes 50 c, 50 c′.

Referring to FIG. 23, once there is sufficient space for implanting thetotal joint replacement 10 between the first and second bones 12, 14 thefoot 26 may be plantar flexed (shown) to achieve better access to thesecond resected tissue surface 104. In one embodiment, a sizer 236 isinserted over the second resected tissue surface 104. The sizer 236 maybe used to measure the size of the second resected tissue surface 104such as the anterior/posterior depth and the medial/lateral width. Inone embodiment, the sizer 236 has a general shape and size of the datum108. The appropriately sized datum 108 may be determined by adding, orleaving, a predetermined distance (e.g. 3 mm) to each medial/lateralside of the sizer 234. In one embodiment, a different sizer 234 isprovided for each datum size. In one embodiment, the size of the sizer234 and right or left foot 26 being measured is indicated by indicia 238such as printed words (e.g. left ankle, size small). The sizer 234 mayincluded a handle 240 that is color coded to the size of the sizer 234.In an alternative embodiment, the sizer 234 is at least partiallytransparent with nested outlines (not shown) of differently sized datum108 that allow a user to select the appropriate size. In one embodiment,the size of the first endoprosthetic component 18 is verified bymeasuring the distance between the medial and lateral malleolus 12 e, 16a. In one embodiment, the sizer 234 is outlined or traced on the secondresected tissue surface 104 using a marking material such as a skinmarker to help indicate the position the datum 108. The sizer 234 may beproperly positioned by aligning the handle 240 with a second metatarsal26 a of the foot 26.

Referring to FIGS. 24 and 25, once the appropriately sized datum 108 isselected, the datum 108 is attached and secured to the distractor 120.In one embodiment, the datum 108 is positioned relative to the alignmentblock 38 using a guide (not shown). The datum 108 may be inserted ontothe second resected tissue surface 104 using the distractor 120 and maybe generally positioned within the outline previously marked on thesecond resected tissue surface 104. In one embodiment, the datum 108 ispositioned on the second resected tissue surface 104 by aligning thedistractor 122 with the second metatarsal 26 a. In one embodiment, theC-arm or other imaging device is used to further verify the position ofthe datum 108 with respect to the second surface 104. In one embodiment,the paddle 140 engages the first resected tissue surface 100 in theinsertion position (FIG. 24) and the upper handle 136 is squeezed towardthe lower handle 130 to separate the first resected tissue surface 100from the second resected tissue surface 104. The ratchet 142 may holdthe upper and lower handles 136, 130 in position with respect to eachother such that the distractor 120 can be held in a distracted positionwithout having to continually squeeze the handles 130, 136.Alternatively, the ratchet 142 may be disengaged and is folded inwardlyto lay on the lower handle 130 (see FIG. 10D).

With the first resected tissue surface 100 distracted from the secondresected tissue surface in the distraction position (FIG. 25), the datum108 may be secured to the second resected tissue surface 104 byinserting the shoulder pins 114 through the pin apertures 112 of thedatum 108. Once the datum 108 is sufficiently secured to the secondresected tissue surface 104, the distractor may be returned to theinsertion position (FIG. 24), the datum lock 126 is released and thedistractor 120 is removed from the ankle 24 leaving the datum 108 inplace on the second resected tissue surface 104 (FIG. 26).

Referring to FIG. 27, once the datum 108 has been secured to the secondresected tissue surface 104, the third tissue resection guide 146 isreleasably secured to the datum 108. A second tissue resection tool 170may be inserted within the second frame 160 and guided by the guide path166 of the second frame 160 to resect the second bone 14 relative to thedatum 108 and expose the third resected tissue surface 104 a. In oneembodiment, the second tissue resection tool 170 is slid back and forthwithin the second frame 160 and along the first side 108 a of the datum108 such that the cutting end 170 a resects tissue proximate the datum108. The second tissue resection tool 170 may be viewed through the openperimeter 160 c. In one embodiment, the second tissue resection tool 170is removed from the third tissue resection guide 146 to inspect thethird resected tissue surface 104 a.

Referring to FIG. 28, the third tissue resection tool 168 may beinserted within the enlarged end 154 a of first guide path 154 of thethird tissue resection guide 146. In one embodiment, the third tissueresection tool 168 is inserted until the stop 168 c of the third tissueresection tool 168 abuts the first frame 152. The third tissue resectiontool 168 may be guided proximate the fourth side 108 e of the datum 108to resect or cut the second bone 14 and expand the second resectedtissue surface 104 away from the fourth side 108 e of the datum 108. Inone embodiment, the fourth side 108 e of the datum 108 nearly contactsthe head 170 a of the third tissue resection tool 170. The third tissueresection tool 168 may be guided back along the first guide path 154 andthe cutting head 168 a may be removed from the first guide path 154through the enlarged end 154 a.

Referring to FIG. 29, in one embodiment, the third tissue resection tool168 is inserted within the enlarged end 156 a of second guide path 156.The third tissue resection tool 168 may be inserted until the stop 168 bof the third tissue resection tool 168 abuts the first frame 152 of thethird tissue resection guide 146. The third tissue resection tool 168 isguided proximate the fourth side 108 e of the datum 108 to resect or cutthe second bone 14 and expand the second resected tissue surface 104away from the fourth side 108 e of the datum 108. The third tissueresection tool 168 is guided back along the second guide path 156 andthe cutting head 168 a is removed from the second guide path 156 throughthe enlarged end 156 a.

Referring to FIG. 30, the third tissue resection guide 146 may beremoved from the datum 114 revealing the third and fourth resectedtissue surfaces 104 a, 104 b left after use of the third tissueresection guide 146.

Referring to FIGS. 31 and 32, the fourth tissue resection guide 176 maybe releasably secured to the datum 108. In one embodiment, the datum 108remains in the same position on the second resected tissue surface 104for use with both the third and fourth tissue resection guides 146, 176.Once the fourth tissue resection guide 176 is secured to the datum 114,the fourth tissue resection tool 182 may be inserted into the firstguide path 180 c of the first frame 180. In one embodiment, the fourthtissue resection tool 182 is inserted into the first guide path 180 c ofthe first frame 180 in the posterior anatomical direction until afeature such as the depth marking 182 a of the fourth tissue resectiontool 182 aligns with a feature of the first frame 180 such as an edge180 f. The fourth tissue resection tool 182 may be slid and/or pivoteddownwardly though the first guide path 180 c until the upper edge 182 bof the fourth tissue resection tool 182 aligns with the alignment line188. The proximal end of the fourth tissue resection tool 182 may bepulled upwardly to contact the edge 180 b of the first frame 180 tothereby pivot the distal end of the fourth tissue resection tool 182downwardly toward and into the second bone 14.

In one embodiment, the fourth tissue resection tool 182 is inserted intothe second guide path 190 c of the second frame 190. In one embodiment,the fourth tissue resection tool 182 is inserted into the second guidepath 190 c in the posterior anatomical direction until a feature such asthe depth marking 182 a of the fourth tissue resection tool 182 alignswith a feature of the second frame 190 such as an edge 190 f. The fourthtissue resection tool 182 may be slid and/or pivoted downwardly thoughthe second guide path 190 c until the upper edge 182 b of the fourthtissue resection guide 182 aligns with the alignment line 194. Theproximal end of the fourth tissue resection guide 182 may be pulledupwardly to contact the edge 190 b to thereby pivot the distal end ofthe fourth tissue resection guide 182 downwardly toward and into thesecond bone 14.

Referring to FIG. 33, the fourth tissue resection guide 176 and thedatum 108 may be removed from the second bone 14 to expose the secondthird, fourth, fifth and sixth resected tissue surfaces 104, 104 a, 104b, 104 c, 104 d. In one embodiment, the resected tissue surfaces 104,104 a, 104 b, 104 c, 104 d are inspected for any burrs and/or missed ormiss cut portions. The resected tissue surfaces 104, 104 a, 104 b, 104c, 104 d may be resected further if necessary using the instrumentationabove and/or through free hand resection.

Referring to FIG. 34, the window trial 198 may be used to furtherevaluate the second resected tissue surface 104 and the various cutsmade to the second bone 14. The window trial 198 may be installed orinserted over the second resected tissue surface 104 using a tool, suchas forceps, attached to the handle 202. If the resections made to thesecond bone 14 are off, the inner surface 198 a of the window trial 198will be at least partially raised off of the second resected tissuesurface 104 and/or tissue will be visible through one or more of theopenings 200. In one embodiment, if the window trial 198 does not fitand/or if excess tissue is visible through the openings 200, a bone rasp(not shown) or other resection device is used to clean up the resectionsand provide a better fit with the window trial 198 and ultimately thefirst endoprosthetic component 18. The window trial 198 may be pinned tothe second bone 14 using one or more pins 42. A keel mill or wire driver(not shown) may be used to cut a keel slot (not shown) into the secondbone 14 using the fin aperture 200 e as a guide. In one embodiment, akeel broach (not shown) is used to clean any remaining tissue in thekeel slot.

Referring to FIG. 35, the barrel cut guide 208 may be attached to thefirst bone 12. In one embodiment, the barrel cut guide 208 is configuredto utilize the same pins 42 and/or pin holes in the first bone 12 thatwere used to secure the first positioning block 50 to the first bone 12.In one embodiment, the support plate 212 is generally flush against thefirst resected tissue surface 100. The position of the barrel cut guide208 toward and away from the first bone 12 may be adjusted with theheight adjuster 214. The window trial 198 may be left on the secondresected tissue surface 104 to protect the second resected tissuesurface 104 during installation and use of the barrel cut guide 208. Inone embodiment, a joint spacer 242 having the general shape and size ofthe middle endoprosthetic component 22 of the total joint replacement 10is inserted between the window trial 198 and the support plate 212 tokeep the support plate 212 in contact with the first resected tissuesurface 100. The joint spacer 242 may also be used to determine theappropriate size and shape of the middle endoprosthetic component 22.

A fifth tissue resection tool 210 may be inserted into the apertures 216a of the barrel cut guide 208 to create the resected cavities 12 a. (SeeFIG. 1). A barrel broach (not shown) may be used to clean the cavities12 a of remaining bone. The resected cavities 12 a may be opened orexposed through the first resected tissue surface 100 by using the fincutter 218. The fin cutter 218 is inserted into the apertures of thebarrel cut guide 208 to remove the section of bone between the resectedcavities 12 a and the first resected tissue surface 100 such that theprojections 20 a may extend from the second endoprosthetic component 20into the resected cavities 12 a. The resected bone may be removed fromthe ankle 24 by any suitable technique.

In one embodiment, the size of the resected cavities 12 a is assessedusing a trial bearing 244. (See FIG. 14). The window trial 198, thejoint spacer 242 and the barrel cut guide 208 may be removed from theankle 24. The first endoprosthetic component 18 may be inserted over thesecond resected tissue surface 104. In one embodiment, an impactor (notshown) is used to seat the first endoprosthetic component 18 on thesecond resected tissue surface 104. A notched end 234 d of the spaceevaluator 234 (see FIG. 10) may be used to lift an anterior edge of thefirst endoprosthetic component 18 and drive the posterior of the firstendoprosthetic component 18 inferiorly in an effort to seat the firstendoprosthetic component 18 on the second resected tissue surface 104.In one embodiment, the second endoprosthetic component 20 is implantedor mounted using an insertion device (not shown). The projections 20 amay be aligned with the resected cavities 12 a. In one embodiment, amallet (not shown) is used to gently drive the second endoprostheticcomponent 20 downwardly and into position on the first bone 12. Ananterior edge of the second endoprosthetic component 20 may be flushwith the anterior tibial cortex. In one embodiment, a sponge (not shown)is placed over the first endoprosthetic component 18 to protect thefirst endoprosthetic component 18 while the second endoprostheticcomponent 20 is being inserted. Variously sized and shaped joint trialsor spacers 242 may be inserted between the first and secondendoprosthetic components 18, 20 to evaluate desired joint tension andposition. After a satisfactory reduction is accomplished, the jointspacer 242 may be replaced with the appropriate middle endoprostheticcomponent 22. The incision 24 may then be closed.

The bone removed from the first and second bones 12, 14 using the aboveinstrumentation and methods may be kept to a minimum. In one embodiment,the reduced amount of bone resection achieved as a result of the aboveprocedures means that if the total joint replacement 10 needs to beremoved and a salvage ankle joint fusion performed, the patient will nothave a noticeable leg-length discrepancy.

Tissue Resection Kit

In one embodiment, a tissue resection kit (not explicitly shown) forimplanting the total joint replacement 10 is provided and includes anycombination of the above instrumentation. In one embodiment, the tissueresection kit includes the datum 108 and one or more tissue resectionguides (e.g., the third and fourth resection guides 146, 176) that aresize and configured to releasably engage the datum 108 and guide atissue resection tool. In one embodiment, the tissue resection guide ofthe tissue resection kit includes the third tissue resection guide 146.In one embodiment, tissue resection guide of the tissue resection kitincludes the fourth tissue resection guide 176. The tissue resection kitmay include the first tissue resection guide 66. The tissue resectionkit may include the spacer guide 78. The tissue resection kit mayinclude the second tissue resection guide 90. The tissue resection kitmay include the sizer 236. The tissue resection kit may include thedistractor 120. The tissue resection kit may include the window trial198. The tissue resection kit may include the barrel cut guide 208. Thetissue resection kit may include the fin cutter 218. In one embodiment,the tissue resection kit includes more than one of the same instrumentor component but of various sizes. The tissue resection kit may includeinstrumentation for one of the left and right ankle 24. The tissueresection kit optionally includes instrumentation for both left andright ankle 24.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concept thereof. It is understood,therefore, that this invention is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the appended claims. For example, specific features of theexemplary embodiments may or may not be part of the claimed inventionand combinations of disclosed embodiments may be combined. The words“right”, “left”, “lower” and “upper” designate directions in thedrawings to which reference is made. The words “inwardly” and“outwardly” refer to directions toward and away from, respectively, thegeometric center of the device. Unless specifically set forth herein,the terms “a”, “an” and “the” are not limited to one element but insteadshould be read as meaning “at least one”.

Further, to the extent that the methods do not rely on the particularorder of steps set forth herein, the particular order of the stepsshould not be construed as limitation on the claims. The claims directedto the method of the present invention should not be limited to theperformance of their steps in the order written, and one skilled in theart can readily appreciate that the steps may be varied and still remainwithin the spirit and scope of the present invention.

1. (canceled)
 2. A spacer guide comprising: a central body extendingbetween a first end and a second end, the central body having a firstwidth at the second end; an extension arm extending from the second endof the central body, and a plurality of projections disposed on a firstsurface of the extension arm, wherein the extension arm has a secondwidth parallel to the first width and measured across the extension armat one of the plurality of projections, the second width narrower thanthe first width.
 3. The spacer guide of claim 2, further comprising aplurality of projections disposed on a second surface of the extensionarm, the second surface opposite the first surface.
 4. The spacer guideof claim 3, wherein each of the plurality of projections disposed on thesecond surface of the extension arm is directly opposite one of theplurality of projections disposed on the first surface of the extensionarm.
 5. The spacer guide of claim 4, wherein the plurality ofprojections on the first surface and the plurality of projections on thesecond surface are cylindrically shaped pins that extend orthogonallyfrom the first surface and the second surface, respectively.
 6. Thespacer guide of claim 5, wherein the plurality of projections on thefirst surface include at least five projections and the plurality ofprojections on the second surface include at least five projections. 7.The spacer guide of claim 2, wherein the central body includes a firstedge extending between the first end and the second end, the first edgefurther extending from the second end along a length of the extensionarm such that the first edge extends continuously from the first end toan end of the extension arm remote from the second end.
 8. The spacerguide of claim 7, wherein the first edge is flat along the central bodyand convex along the extension arm.
 9. The spacer guide of claim 2,wherein the extension arm has a length extending between the second endof the central body and a free end of the extension arm, the lengthbeing greater than a distance between the first end and the second endof the central body.
 10. The spacer guide of claim 9, wherein the freeend of the extension arm is further from the second end of the centralbody than any other location on the extension arm.
 11. The spacer guideof claim 2, wherein the first surface is planar and extends over theextension arm and the central body.
 12. The spacer guide of claim 2,further comprising a mount extending from the second end of the centralbody, the mount separated from the extension arm by the central body andsized for disposal in a slot of a bone resection guide.
 13. A method ofpositioning instrumentation used in ankle surgery, the methodcomprising: attaching the spacer guide of claim 2 to a bone resectionguide; and viewing a bone to be resected from a lateral side of thespacer guide.
 14. A spacer guide comprising: a central body; anextension arm extending from the central body, and a plurality ofprojections disposed on a first surface of the extension arm and on asecond surface of the extension arm, the second surface opposite thefirst surface, wherein the first surface of the extension arm isparallel to the second surface of the extension arm.
 15. The spacerguide of claim 14, wherein the first surface of the extension arm isplanar.
 16. The spacer guide of claim 14, further comprising a mountextending from the central body, the mount separated from the extensionarm by the central body and sized for disposal in a slot of a resectionguide.
 17. The spacer guide of claim 14, wherein each of the pluralityof projections disposed on the second surface of the extension arm isdirectly opposite one of the plurality of projections disposed on thefirst surface of the extension arm.
 18. The spacer guide of claim 17,wherein the plurality of projections on the first surface and on thesecond surface are cylindrically shaped pins that extend orthogonallyfrom the first surface and the second surface, respectively.
 19. Thespacer guide of claim 18, wherein the plurality of projections on thefirst surface include at least five projections and the plurality ofprojections on the second surface include at least five projections. 20.The spacer guide of claim 19, wherein the plurality of projections onthe first surface are positioned such that each projection is located ata unique location on a length of the extension arm, the length measuredfrom the central body to a free end of the extension arm.
 21. A methodof positioning instrumentation used in ankle surgery, the methodcomprising: inserting the spacer guide of claim 14 into a slot of a boneresection guide; and viewing a bone from a lateral side of the spacerguide to evaluate a path of bone resection, wherein the bone resectionguide is positioned over the bone so that a plane through the slot isalso a resection plane.